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דרושים Associate Senior Fellow Clinical Scientist ב-Boston Scientific ב-United States, Marlborough

מצאו את ההתאמה המושלמת עבורכם עם אקספוינט! חפשו הזדמנויות עבודה בתור Associate Senior Fellow Clinical Scientist ב-United States, Marlborough והצטרפו לרשת החברות המובילות בתעשיית ההייטק, כמו Boston Scientific. הירשמו עכשיו ומצאו את עבודת החלומות שלך עם אקספוינט!
חברה (1)
אופי המשרה
קטגוריות תפקיד
שם תפקיד (1)
United States
אזור
Marlborough
נמצאו 88 משרות
Today
BS

Boston Scientific Senior Regulatory Affairs Specialist - Endoscopy United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Develop and implement regulatory strategies for new and modified medical devices. Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle. Draft and...
תיאור:


At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in

We continue to invest in innovation across both established platforms and new pipeline development. As a, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.


• Develop and implement regulatory strategies for new and modified medical devices
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Serve as company representative in communications with regulatory agencies regarding submission strategy, testing requirements, and clarification or follow-up during review
• Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization


• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•in Regulatory Affairs within the medical device industry
• Strong working knowledge of
• General understanding of
• Familiarity with regulations related to the conduct of clinical trials
• Ability to manage multiple regulatory projects simultaneously


• Experience preparing and submitting, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with minimal supervision

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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Today
BS

Boston Scientific Senior Clinical Trial Manager Oncology United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Leading and driving the cross-functional project team in the planning, execution, and operational management of oncology clinical trials. Designing, directing, and executing global clinical studies in alignment with program strategy,...
תיאור:

Your responsibilities will include:

  • Leading and driving the cross-functional project team in the planning, execution, and operational management of oncology clinical trials
  • Designing, directing, and executing global clinical studies in alignment with program strategy, approved budget, and timelines, in compliance with regulatory and operational procedures
  • Collaborating on development and oversight of internal and external project materials, including study manuals, systems, and regulatory submissions
  • Interfacing and building relationships with external physicians and key opinion leaders (KOLs)
  • Managing clinical trial budgets (up to 25%), including monthly tracking, forecasting, and variance analysis
  • Providing direction to Contract Research Organizations (CROs) and external vendors
  • Ensuring audit readiness and compliance across all clinical trial activities
  • Leading proactive risk identification, assessment, and mitigation planning for assigned studies
  • Preparing and delivering study updates, presentations, and risk assessments to leadership
  • Contributing clinical insights to product development activities and serving as a Clinical team representative on product development teams
  • Traveling domestically up to 10–25%, as required

Required qualifications:

  • Bachelor’s degree and minimum of 5 years' experience in oncology-related clinical research or equivalent education and work experience
  • Minimum of 1 yearof direct oncology clinical trial management experience
  • Minimum of 1 yearof financial oversight and budget management experience
  • Minimum of 1 yearworking with CROs, vendors, or outsourced clinical operations

Preferred qualifications:

  • Experience in early feasibility studies, solid tumor trials, or immuno-oncology (IO) product development
  • Background working with engineering or product development teams
  • Strong ability to:
    • Generate new ideas and approaches by applying creative thinking to complex problems
    • Align execution with strategic goals and independently drive action without close supervision
    • Collaborate and influence across global, cross-functional teams
    • Adapt quickly and stay effective under changing conditions

Maximum Salary: $ 243000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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משרות נוספות שיכולות לעניין אותך

Today
BS

Boston Scientific Clinical Supply Chain Planner United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Partner with other Clinical Supply Chain team members to complete and approve the Device Management plan prior to the start of study enrollment. Participate in the Device Management system user...
תיאור:

About the Role:

At Boston Scientific, the Supply Chain Planner I support the Clinical Supply Chain (CSC) organization by supporting the device distribution and tracking of investigational products from the trial planning phase through final reconciliation of products. This role involves coordinating with internal and external groups to meet clinical trial deliverables while ensuring regulatory compliance. Responsibilities include demand planning, data analysis, inventory management, document tracking, and ensuring clinical objectives are met within time, budget, and compliance parameters.

Your Responsibilities Include:

  • Partner with other Clinical Supply Chain team members to complete and approve the Device Management plan prior to the start of study enrollment.
  • Participate in the Device Management system user acceptance testing.
  • Assist in developing demand plans and ensuring appropriate and timely supply for clinical trials.
  • Engage with clinical team, customer care, distribution, and logistics teams to ensure product is distributed in a timely and compliant manner for clinical trials.
  • Engage with external groups/vendors, when used, to ensure distribution and processes are in place to support on time enrollment within compliance.
  • Monitor trial performance and inventory position as to reduce excess, expired and obsolete inventory (EE&O) risk.
  • Using data models and device accountability systems to analyze and ensure that investigational devices are tracked throughout the clinical trial.
  • Collaborate with internal and external groups to return and track un-used product into our distribution centers and to final device disposition.
  • Support Vendor Management activities with existing or new trials.
  • Escalate issues and potential risks to CSC management as applicable.

Qualifications Required:

  • Bachelor’s degree in supply chain or equivalent work experience required.
  • Strong Analytical skills with ability to structure and perform data analysis.
  • Experience solving urgent and complex business challenges.
  • Excellent communication and relationship management skills.
  • Strong Organization skills to work multiple issues in parallel over time.
  • Strong PC skills, including Excel, Word, and Power Point.
  • Adhere to procedures and practices that maintain compliance to regulations.

Qualifications Preferred:

  • Medical devices/pharmaceutical clinical trials and device distribution experience preferred.
    Sales, Inventory, and Operations Planning (SI&OP) experience is a plus.
  • Experience utilizing SAP or other ERP system preferred.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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משרות נוספות שיכולות לעניין אותך

Today
BS

Boston Scientific Senior Global EHS Director United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
A visionary EHS leader with a track record of driving change across complex global organizations. A collaborator, innovator, and strategist who sees challenges as opportunities. A purpose-driven professional ready to...
תיאור:

This is more than a role. It’s a movement.

🌿Carbon Neutrality by 2030Be the architect of our transformation as we drive our major manufacturing and distribution centers toward carbon neutrality—setting a new standard for sustainable innovation.

♻️Design and execute a global zero waste roadmap by 2030, embedding circularity into every layer of our operations.

Who You Are:

  • A visionary EHS leader with a track record of driving change across complex global organizations.
  • A collaborator, innovator, and strategist who sees challenges as opportunities.
  • A purpose-driven professional ready to leave a legacy of impact.

Because here, your work saves lives—and your leadership shapes the future. You’ll join a company that’s committed to doing what’s right for patients, employees, and the planet. And you’ll be part of a team that’s not just talking about change—we’re making it happen.


The position requires strategic vision and hands-on implementation to build world-class EHS performance based on a strong global culture. They work closely with various functions, facilities and geographies to develop, implement and sustain EHS programs, policies and procedures that deliver the required high performance. Such strategies and programs are developed in harmony with the Companies business objectives and are aligned with its growth trajectory. The Snr. EHS Director is responsible for EHS performance at over 20 manufacturing sites and more that 120 commercial locations with a workforce of circa. 60,000. Working closely with a network of 200 EHS and Occupational Health professionals they deliver a vital two-way connection between senior leadership and site operations.


Strategic Leadership:

  • Partners with key senior leadership within BSC to ensure EHS strategies are aligned with business needs and EHS challenges are communicated upwards.
  • Delivers strong leadership within the EHS community across all geographical regions establishing common purpose and focus on key performance.
  • Exhibits the leadership qualities of trust, integrity, courage, clear communication and loyalty in all personal actions and ensures they are fostered in the broader EHS community.
  • Ensures visible and impactful EHS leadership to the broader business stakeholders.
  • Understands the leadership challenges of others to facilitate the necessary partnerships for effective EHS management.
  • Builds and develops an EHS staff that has the skills, competencies and abilities to meet the current and future needs of the Company at both a global and local level.

Strategy and AOP:

  • Develops a Global EHS strategy that delivers the required EHS performance while supporting the company business needs.
  • Ensure Global strategy is cascaded into all levels of the organization, is embedded in local strategies and monitored to ensure effective delivery.
  • Create and maintain a process for local EHS issues and challenges to be communicated to Global EHS, enabling their inclusion in the global strategies where necessary.
  • Achieve senior leadership agreement with the EHS strategy to drive successful outcomes.
  • Envisions potential challenges 5 to 10 years out and builds protective strategies, processes and structures to protect the business and enable its continued unhindered development.

EHS Operational Excellence:

  • Ensures compliance to the Global EHS policy and enhances implementation by providing core operational guidance for all the locations and regions.
  • Ensures all manufacturing and Tier I Distribution locations are certified to ISO14001: Environmental Management Standard and the ISO45001: Health and Safety management standard.
  • Identifies and ensures the development of Global Standards for key EHS programs, oversees their deployment and ensures verification of effectiveness.
  • Delivers and maintains EHS digital platforms that enables global connectivity across all key programs, communicates real-time performance and enables early flagging of emerging challenges.
  • Deliver impactful risk control and risk mitigation through structures risk analysis and problem-solving techniques.
  • Ensures EHS risk-informed strategies are in place for key operational aspects, spanning Global Supply Chain, Commercial activities and Acquisitions & Integrations.

Compliance Assurance:

  • Ensures the Company is aware of, and compliant to, all EHS regulatory requirements at local, regional and global level by maintaining an effective compliance assurance program.
  • Delivers surveillance of pending EHS regulations, globally, regionally and locally, which enables early response. Maintains the company EHS compliant while ensuring the Company business needs are advocated for.
  • Represents the Company within relevant trade associations, professional bodies and industry groupings on EHS topics relevant to the Company.

Occupational Health:

  • Oversees a Global Occupational Health service that focuses on employee health, medical accommodations, return to work and employee wellness; supporting both the employee and the business.
  • Ensures occupational health support services are available for all employees globally and emergency advice contacts are in place.
  • Ensure the development and upskilling of the global Occupational Health Nurses is supported to maintain required competencies as new requirements emerge.

Performance:

  • Establishes key EHS performance targets for Environment, Health and Safety across the entire organization that drive meaningful continuous improvement while aligned to the needs and abilities of the business, both globally and locally.
  • Maintains a live tracking and reporting process for delivery of the agreed EHS performance targets with escalation and reaction mechanisms where needed.
  • Ensures positive performances are recognized and celebrated.
  • Establishes a positive EHS performance culture where delivery of EHS goals, both within the function and across other functions, is the norm.

Acquisitions and Integrations:

  • Ensures availability and provision of EHS supports to Acquisition and Integration teams for Due Diligence, EHS Criticality assessments, gap assessments, integration plans and resourcing planning.
  • Ensures acquisition Integrations are supported and actively facilitated as they adapt to the new BSC culture, programs and operational requirements.

Required Qualifications:

  • Bachelor’s degree required preferably within Environmental Sciences or in an engineering discipline.
  • 10+years of EH&S experience to include standard concepts, practices, and procedures within the EH&S field.
  • 5+ years of people leadership experience, ability to guide, coach, direct, and develop direct reports, and drive those practices throughout their organization.
  • Experience in controlling the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Proven ability to work through other functions and personnel to deliver on EHS goals while supporting the business locally and globally.
  • Demonstrated experience collaborating with global business partners, building inclusive partnerships and valuing diversity across cultures and regions.
  • Strong communication and presentation skills required, with ability to influence and drive new ideas at the executive level.
  • Self-starter with high degree of latitude is required.
  • This role requires travel domestic and international to BSC global locations.

Preferred Qualifications:

  • MS or MBA preferred
  • Global, multi-site experience is strongly preferred
  • Medical Devices industry experience

Maximum Salary: $ 327800

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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משרות נוספות שיכולות לעניין אותך

Yesterday
BS

Boston Scientific Global Regulatory Compliance Senior Manager United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule. Partner with Quality leaders across...
תיאור:

About the role:

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

  • Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
  • Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.
  • Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
  • Act as the sub-process steward for the global Internal Audit process.
  • Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
  • Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
  • Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
  • Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.
  • Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.
  • Act as a CAPA owner for corrective actions necessary to improve the global processes.
  • Champion departmental or cross-functional quality initiatives.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

  • Minimum of Bachelor’s degree in relevant field
  • Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
  • Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
  • Demonstrated inclusive leadership skills
  • High degree of integrity, professionalism, and the ability to establish credibility internally and externally
  • High sense of urgency and commitment to execution
  • Ability to travel up to 25 - 30% domestically and internationally

Preferred qualifications:

  • Advanced degree
  • Pharmaceutical experience
  • Digital product ownership and/or IT project experience
  • Strong analytical and communication skills

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Show more

משרות נוספות שיכולות לעניין אותך

Yesterday
BS

Boston Scientific Senior Analytics Engineer United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Additional Duties:. Oversees development builds associated with the project using special work requests. Writes and reviews validation protocols and reports applicable to new processes. Plans, organizes, and conducts all aspects...
תיאור:

Costa Rica-Coyol

Hybrid Roles:

About the role:

Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of new product into production.

Mechanical Design (Mechatronics-Oriented):

•using(e.g.,).
• Apply knowledge ofto design robust, cost-effective equipment.
• Work with,, andto validate designs.
•() into automated process equipment.
• Ensureduring the design phase ().
• Collaborate with vendors and fabrication shops forprototyping and commissioning.
•using(e.g.,).
• Apply knowledge ofto design robust, cost-effective equipment.
• Work with,, andto validate designs.
•() into automated process equipment.
• Ensureduring the design phase ().
• Collaborate with vendors and fabrication shops for.

Process Control & Automation:

Design, configure, and optimize automated process control systemsusing,, andSCADA.
Develop and maintain, and(e.g.,Modbus, EtherNet/IP, CANopen).
Apply(e.g.,) forprocess optimization, stability, and performance monitoring.
Interface control systems with, andindustrial robotics.
Implementfor,, and.

Process Engineering & Continuous Improvement:

• Leadandreviews.
• Evaluate and improve, and.
• Implement,, andpractices.
• Conductand.
• Supportthrough early involvement in design phases.
• Assess, prioritize, andon platform or derivative projects.
• Apply technical knowledge to.
• Execute theassociated with the,, and.
• Ensureis completed to meet(e.g.,).
•.

May supervise Technicians and Engineersto achieve project goals.

  • Additional Duties:
  • Oversees development builds associated with the project using special work requests.
  • Writes and reviews validation protocols and reports applicable to new processes.
  • Plans, organizes, and conducts all aspects of technical reviews.
  • Provides Design for Manufacturability (DFM) input to the engineering print package.
  • Contributes ideas to or generates Intellectual Property submissions.
  • Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
  • May serve as a core team member or extended team member on new product projects.

Minimum Requirements

  • Bachelor’s or Master’s Degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
  • 7+ years of experience in process engineering, mechanical design, and control system integration in a manufacturing or industrial automation setting.
  • Proven experience in:
  1. 3D mechanical CAD tools (e.g., SolidWorks, PTC Creo, AutoCAD)
  2. PLC/HMI development (e.g., Siemens TIA Portal, Allen-Bradley RSLogix/Studio 5000)
  3. Motion control systems (e.g., servo drives, stepper motors, pneumatics)
  4. Control systems programming, electrical panel layout, and troubleshooting.
  5. Strong understanding of mechatronic system integration—including mechanical, electrical, and software interfaces.
  6. Familiar with robotics, machine vision, and industrial communication protocols.
  7. Experience with process documentation (P&IDs, control narratives, wiring diagrams).
  8. Ability to lead cross-functional teams and drive projects from concept to production.

Preferred Qualifications:

  • Experience with MATLAB/Simulink or other modeling/simulation tools.
  • Familiarity with NI LabVIEW, Python, or C/C++ for custom test or automation tools.
  • Experience in regulated industries (medical device, automotive, aerospace, or semiconductor).
  • Professional Engineer (PE) license or relevant certifications (e.g., Six Sigma Black Belt).
  • Knowledge of Industry 4.0, IoT-enabled manufacturing, and digital twin technologies.

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משרות נוספות שיכולות לעניין אותך

Limitless High-tech career opportunities - Expoint
Develop and implement regulatory strategies for new and modified medical devices. Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle. Draft and...
תיאור:


At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in

We continue to invest in innovation across both established platforms and new pipeline development. As a, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.


• Develop and implement regulatory strategies for new and modified medical devices
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Serve as company representative in communications with regulatory agencies regarding submission strategy, testing requirements, and clarification or follow-up during review
• Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization


• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•in Regulatory Affairs within the medical device industry
• Strong working knowledge of
• General understanding of
• Familiarity with regulations related to the conduct of clinical trials
• Ability to manage multiple regulatory projects simultaneously


• Experience preparing and submitting, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with minimal supervision

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).


For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Show more
בואו למצוא את עבודת החלומות שלכם בהייטק עם אקספוינט. באמצעות הפלטפורמה שלנו תוכל לחפש בקלות הזדמנויות Associate Senior Fellow Clinical Scientist בחברת Boston Scientific ב-United States, Marlborough. בין אם אתם מחפשים אתגר חדש ובין אם אתם רוצים לעבוד עם ארגון ספציפי בתפקיד מסוים, Expoint מקלה על מציאת התאמת העבודה המושלמת עבורכם. התחברו לחברות מובילות באזור שלכם עוד היום וקדמו את קריירת ההייטק שלכם! הירשמו היום ועשו את הצעד הבא במסע הקריירה שלכם בעזרת אקספוינט.