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דרושים Principal Product Risk Specialist ב-Boston Scientific ב-United States, Marlborough

מצאו את ההתאמה המושלמת עבורכם עם אקספוינט! חפשו הזדמנויות עבודה בתור Principal Product Risk Specialist 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 71 משרות
23.11.2025
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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23.11.2025
BS

Boston Scientific Salesforce Product Owner Urology United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Align product goals with business strategy, sales enablement objectives, and customer engagement initiatives. Serve as the primary liaison between business teams and Salesforce technical teams. Collaborate with cross-functional partners to...
תיאור:



• Define and communicate a clear product vision and roadmap for Salesforce and related CRM solutions
• Align product goals with business strategy, sales enablement objectives, and customer engagement initiatives
• Serve as the primary liaison between business teams and Salesforce technical teams
• Collaborate with cross-functional partners to ensure seamless connectivity across all digital tools used by sales representatives


• Own and prioritize the Salesforce product backlog based on business value and impact
• Write detailed user stories and acceptance criteria to ensure clarity and alignment
• Partner with the Digital Product Manager, Salesforce developers, admins, and architects to refine and groom backlog items


• Engage with sales, marketing, service, and operations teams to gather and analyze requirements
• Manage stakeholder expectations and provide transparency on product priorities, timelines, and releases
• Participate in Agile ceremonies including sprint planning, backlog grooming, and review sessions


• Work with technical teams to ensure timely delivery of new features, integrations, and enhancements
• Oversee testing, deployment, and post-launch validation of Salesforce releases
• Ensure proper documentation, training, and change management for end users


• Maintain a strong understanding of Salesforce platform capabilities, data models, and best practices
• Ensure adherence to governance, security, and compliance standards
• Monitor performance metrics and user feedback to identify areas for improvement


• Bachelor’s degree in Business, Information Systems, Computer Science, or a related field
• Minimum of 3 years' experience as a Product Owner, Business Analyst, or similar role, ideally with Salesforce as a primary platform
• Proven track record leading cross-functional teams in an Agile/Scrum environment
• Strong understanding of CRM processes and the Salesforce ecosystem
• Excellent communication, stakeholder management, and prioritization skills
• Analytical and data-driven mindset


• 5 or more years' experience in a Salesforce-focused role
• Hands-on experience with Salesforce Sales Cloud, Service Cloud, or Experience Cloud
• Salesforce Administrator or Salesforce Platform App Builder certification
• Certified Scrum Product Owner (CSPO) or equivalent Agile certification
• Experience building agentic solutions within Salesforce or other platforms
• Comfortable balancing short-term deliverables with long-term platform vision

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

23.11.2025
BS

Boston Scientific Principal Product Manager Downstream Laser Lithotripsy United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Uses problem-solving methodologies to support issue investigations and make improvements. Actively interacts with cross-functional team members through face-to-face meetings, virtual video calls, emails or group sessions. Practices good teamwork by...
תיאור:

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Key Responsibilities

  • Uses problem-solving methodologies to support issue investigations and make improvements.
  • Actively interacts with cross-functional team members through face-to-face meetings, virtual video calls, emails or group sessions.
  • Practices good teamwork by actively listening, sharing ideas and working together as one team, in support of day-to-day operating requirements.
  • Assists in the development and analysis of process, product, material or equipment specifications and performance requirements
  • Evaluates new equipment/processes/chemicals for environmental impact to eliminate or lessen such impacts in conjunction with Environmental Health and Safety (EHS)As part of personal development, may assume engineering responsibility for manufacturing equipment or processes within the cleanroom environment.
  • Interfaces with vendors, possibly physicians and other technical consultants as part of the role.
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements in Standard Operating Procedures.

Education & Experience

  • NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)
  • An understanding of systems and a willingness to learn and develop technical skills.
  • Good communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision.
  • Eager to learn and active participate.
  • Strong interpersonal skills.
  • Eligible to work in Ireland.
  • Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.
  • – opportunity to transform the lives of patients worldwide.
  • Our Culture- our work is guided by core values that define our culture and empower our employees.
  • Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.
  • Opportunity to Innovate– we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.
  • Work-Life Balance– we have created a culture that acknowledges, respects and supports your life and work choices.
  • Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

To search and apply for open positions, visit:

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משרות נוספות שיכולות לעניין אותך

22.11.2025
BS

Boston Scientific Senior Manager AI Product Portfolio Management United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Lead and mentor AI Product Owners and Program Managers to deliver enterprise-wide AI solutions. Accelerate delivery by using AI to build AI—empower the team with AI-powered processes to drive efficiency...
תיאור:


In this role, you will oversee the delivery of scalable, high-impact AI solutions, working closely with AI Engineering, Platform Managers, and cross-functional teams across the business. You’ll bring an “AI-first” mindset, helping to drive continuous innovation, accelerate development using AI to build AI, and establish best-in-class product management practices for artificial intelligence.

You will also act as a thought leader, staying ahead of emerging technologies, promoting ethical AI practices, and championing enterprise enablement of AI across the organization.

Strategic leadership

  • Lead and mentor AI Product Owners and Program Managers to deliver enterprise-wide AI solutions
  • Accelerate delivery by using AI to build AI—empower the team with AI-powered processes to drive efficiency and speed
  • Execute on a robust AI product and portfolio roadmap aligned with enterprise digital strategy

AI portfolio management and value delivery

  • Own the full AI portfolio lifecycle: intake, prioritization, funding, resource allocation, execution, and value realization
  • Collaborate with business and technical leaders to define and report KPIs for adoption, outcomes, and financial impact
  • Provide regular updates to senior leadership, ensuring strategic alignment and measurable results
  • Streamline end-to-end processes to improve speed and scalability of AI product delivery

Cross-functional collaboration

  • Act as a strategic connector across AI Engineering, Platform, Data Science, IT, Enterprise Architecture, and Business Units
  • Design, implement, and evolve an AI operating model for scalable and sustainable delivery

Agile product operations and governance

  • Champion Agile product delivery practices and AI-enabled tools for backlog management, sprint planning, and reporting
  • Standardize documentation, decision-making gates, and risk management processes

Enterprise AI enablement

  • Lead and scale enterprise-wide AI initiatives with alignment to data governance, compliance, and ethical AI standards
  • Promote reusability of AI capabilities to accelerate time-to-value and reduce duplication

Financial and risk stewardship

  • Manage fiscal planning and performance for the AI portfolio, including annual operating plan development and budget oversight

Thought leadership and innovation

  • Stay current on emerging AI trends (e.g., LLMs, AI agents, prompt engineering) and translate insights into business opportunities

Technical depth and AI literacy

  • Possess a solid understanding of machine learning, large language models, and emerging technologies—not to code, but to ask the right questions and make informed decisions
  • Evaluate feasibility, scalability, and risks of AI solutions
  • Understand data ecosystems, model lifecycle, and system architecture for sustainable AI delivery

Required qualifications:

  • Bachelor’s degree in Business, Engineering, Computer Science, or a related field
  • Minimum of 7 years' experience in digital product management within custom application delivery in a large matrixed organization
  • Proven experience leading and developing product owners to drive value and alignment
  • Demonstrated financial acumen to assess product investments, trade-offs, and ROI
  • Strong familiarity with large language models (LLMs), AI agents, prompt engineering, and enterprise AI use cases
  • Experience collaborating with technical teams such as AI Platform and Engineering on GenAI, AI/ML, and data products
  • Deep interest in emerging AI technologies and their real-world applications
  • Certification in Product Management and/or Agile Scrum (e.g., CSPO, PSPO, SAFe, or equivalent)
  • Skilled in gathering and documenting functional requirements
  • Self-driven leader with an entrepreneurial, AI startup mindset focused on rapid innovation and measurable impact
  • Strong analytical, problem-solving, and communication skills to influence and align stakeholders

Preferred qualifications:

  • Product experience leading an AI product team in a startup environment
  • Experience presenting to stakeholders and gaining buy-in across all organizational levels
  • Proven ability to work independently while engaging cross-functional teams to drive outcomes
  • Demonstrated ability to manage competing priorities in a fast-paced environment
  • Comfortable navigating ambiguity and influencing without direct authority
  • Strong team collaborator with a commitment to supporting others and fostering innovation

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

22.11.2025
BS

Boston Scientific Principal Statistician - DFSS United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Provide statistical expertise and support to R&D using statistical methods associated with product and process development, design assurance, and problem-solving in root cause investigations. Interpret data and provide insight on...
תיאור:

About This Role:

Principal Statistician, you will play a pivotal role in shaping the future of innovation at Boston Scientific. You will provide technical and statistical leadership that empowers teams within Endoscopy and across our global network to deliver breakthrough solutions. Your expertise will be instrumental in driving new product development from concept to launch, ensuring that every decision is grounded in robust data and statistical insight.

You will be a key mentor and trusted advisor, not only for our R&D organization but also for cross-functional teams worldwide. By fostering a culture of learning and continuous improvement, you will elevate the statistical & problem solving acumen of engineers, scientists, and technical professionals, helping them translate complex data into actionable strategies that accelerate product development.

Most importantly, your work will directly contribute to launching innovative products that advance patient care. By guiding teams through the rigorous application of statistical methods, you will help ensure our products meet the highest standards of quality and safety to make a tangible difference in the lives of patients around the world.

Your responsibilities will include:

  • Provide statistical expertise and support to R&D using statistical methods associated with product and process development, design assurance, and problem-solving in root cause investigations.
  • Interpret data and provide insight on the underlying factors driving the results to advise engineers on the best strategies to move forward, not just on the data analysis
  • Apply a variety of statistical analyses and techniques to data generated by R&D, Process Development, and other technical groups.
  • Create and maintain statistics-related procedures and tools for the Marlborough site and the global network.
  • Collaborate with Global Statisticians and cross-functional teams working towards continual improvement of the application and use of statistics across various projects and business initiatives.
  • Identify and lead projects that improve efficiencies in product and process development through designed experiments, reduced sampling methodologies, and advanced or automated data analysis.
  • Provide feedback to cross-functional development teams during design reviews on the application and insights from statistical analysis tools.
  • Develop and deliver training (classroom and virtual options) on the appropriate use of statistical methods with R&D, Process Development, and other technical groups.
  • Perform ad hoc statistical analyses and provide guidance as required.
  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

  • Bachelor's degree in Mathematics, Statistics, Physics, or Engineering
  • 8+ years' experience in an industry role, preferably within medical devices; experience in a regulated environment is required
  • 5+ years' experience using Minitab, Design Expert, or other relevant statistical software
  • Proven ability to apply statistical analysis in a professional setting; highly self-motivated and results-driven

Preferred qualifications:

  • Master’s or PhD in Mathematics, Statistics, Engineering, or a related field
  • Experience working in or closely with R&D or Development Engineering teams
  • Demonstrated application of statistical tools to support project deliverables (e.g., test method validation, design verification testing)
  • Six Sigma Black Belt or Master Black Belt certification

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

22.11.2025
BS

Boston Scientific Sr Quality Systems Engineer- Global Risk Management United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal...
תיאור:

Spencer Gregory Hale


Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

  • Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
  • Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
  • Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
  • Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
  • Supporting internal and external audits and audit responses for existing products.
  • Monitoring compliance with company policies and procedures.
  • Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
  • Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

  • Bachelor's degree in Science, Health, or Engineering.
  • Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
  • Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

  • Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
  • Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
  • Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Maximum Salary: $ 164500

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.

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

22.11.2025
BS

Boston Scientific Senior Product Reporting Analyst United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Executes recurring and ad hoc reporting for PIRs and FAs (i.e. internal and external customers). Requires knowledge of BSC divisions, database entities, data access methodology, Microsoft Office Applications, and business...
תיאור:

Your responsibilities will include:

  • Executes recurring and ad hoc reporting for PIRs and FAs (i.e. internal and external customers). Requires knowledge of BSC divisions, database entities, data access methodology, Microsoft Office Applications, and business specific applications such as FARS and SAP.
  • Performs data quality analysis and analyzes results. Proposes system and/or business process changes, data corrections, etc.
  • Provides training, direction and guidance to peers and other analysts according to established policies and management guidance.
  • Support FA team to assist with planning, communication, and execution strategy of the FA.
  • Support execution of approved FA plan. Assist with delivery of FA message(s) and/or retrieval activities.
  • Conduct post-action reporting and support document archiving and FA closure.
  • Contribute to the development/improvement of department and corporate FA policies and procedures.
  • Manage all report requests per established processes.
  • Functions as the Subject Matter Expert (SME) regarding FA product traceability in representing the associated division and region; this includes but is not limited to internal and external audits, and subject-matter presentations.

Required Qualifications

  • Bachelor’s degree or equivalent years of experience required
  • Minimum of 5 years of related experience
  • 0-10% travel required

Preferred Qualifications

  • Strong organizational, planning and management skills.
  • Strong analytical skills.
  • Strong Microsoft Excel skills.
  • Strong problem solving, verbal, and written communication skills.
  • Ability to coordinate and manage across groups in a matrix organization.
  • Experience with SAP, Microsoft Word, Teams, Outlook, PowerPoint.
  • Preferred experience in medical device industry

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

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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בואו למצוא את עבודת החלומות שלכם בהייטק עם אקספוינט. באמצעות הפלטפורמה שלנו תוכל לחפש בקלות הזדמנויות Principal Product Risk Specialist 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.