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Qa Specialist jobs in United States, Massachusetts, Marlborough

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Job title (1)
United States
Massachusetts
Marlborough
26 jobs found
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...
Description:


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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21.11.2025
BS

Boston Scientific Pre-Authorization Specialist II United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Be placed on a team within Accounting, Internal Audit, or Financial Planning & Analysis (FP&A) within a Division, Corporate, or Global Supply Chain. Work independently on an MBA-level project where...
Description:

Title:MBA Finance Intern

Duration:12 Weeks

We will consider qualified applicants of all ages who are starting (or restarting) their careers

About the Role:

  • Be placed on a team within Accounting, Internal Audit, or Financial Planning & Analysis (FP&A) within a Division, Corporate, or Global Supply Chain.
  • Work independently on an MBA-level project where your findings or solutions will be implemented into the business.
  • Be a valued team member whose ideas are encouraged and supported.
  • Interact with Boston Scientific leadership and collaborate with people committed to innovation in healthcare.
  • Network with the finance community, employee resource groups, and other interns.
  • Meet with an assigned mentor who will be a resource for you throughout your internship and beyond.
  • Present on your work to the finance community including senior management.
  • Interview for a fulltime position in the finance organization to start after graduation from your MBA program.

Your Responsibilities will Include:

Examples of meaningful work by Finance Interns

  • Conducted trended SG&A analysis to identify main drivers of growth and areas of opportunity for investment in support of the divisional annual operating plan target setting process (Urology & Pelvic Health FP&A Intern).
  • Lead forecast accuracy analysis project to identify the main drivers underlying variances in production spending for manufacturing plants (Global Supply Chain FP&A Intern).
  • Performed an audit by examining auditee files, interviewing employees, preparing audit work papers, and presenting findings to senior management (Internal Audit Intern).
  • Advised on potential goodwill impairments by performing both qualitative and quantitative analysis including analyzing strategic plans vs. actual results and meeting with divisional controllers (Technical Accounting Intern).

Required Qualifications:

  • Full-time MBA students with a concentration in Accounting or Finance or full-time MBA students with an undergraduate degree in Accounting or Finance
  • Current MBA (Masters of Business Administration) student with a graduation date between Fall 2026 and Spring 2027
  • Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization
  • Prior work experience in finance and/or accounting or finance/accounting adjacent field

Preferred Qualifications:

  • Highly motivated leader
  • Outstanding verbal and written communication skills
  • Exceptional organization and time management skills
  • Strong Microsoft Excel skills preferred

Maximum Salary: $106,600

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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21.11.2025
BS

Boston Scientific Principal Product Risk Specialist United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.)....
Description:

Your responsibilities will include:
  • Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.). Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis
  • Analyze literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
  • Identifies the need for and/or generates clinical risk related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
  • Serves as a liaison between Clinical Product Risk function and project team. Clearly communicates pertinent project/function information.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.
  • Mentors and serves as subject matter expert in key clinical product risk activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
  • Serve as product SME during FDA, Notified Body, and internal audits; prepare back‑room documentation and CAPA responses.


Required Qualifications:
  • A bachelor’s degree and 5+ years of professional experience in life sciences, engineering, or related field.
  • Or 10+ years of professional experience in the respective field.
  • Medical and/or technical writing experience required
Preferred Qualifications:
  • Medical Device industry experience preferred
  • Therapeutic area knowledge desired
  • Ability to work cross-functionally at all levels of organization
  • Proven ability to analyze, interpret and synthesize clinical and commercial data
  • Attention to detail and strong organizational skills.
  • Understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment and failure to adequately perform tasks can result in noncompliance with governmental regulations.

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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04.09.2025
BS

Boston Scientific Data Analytics Specialist - Finance Automation & United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Maintain and troubleshoot Alteryx workflows that extract and transform data from SAP S4/HANA to support reporting and analytics. Support Tableau dashboard enhancements and performance optimizations. Identify and resolve data quality...
Description:


Key Responsibilities:

  • Maintain and troubleshoot Alteryx workflows that extract and transform data from SAP S4/HANA to support reporting and analytics.
  • Support Tableau dashboard enhancements and performance optimizations.
  • Identify and resolve data quality or integration issues across the pipeline.
  • Collaborate cross-functionally with Finance, Accounting, Tax, and IT teams to ensure reporting accuracy and relevance.
  • Assist in implementing new business requirements, testing enhancements, and deploying updates.
  • Document workflows and maintain knowledge artifacts for ongoing support and auditability.
  • Analyze changes in SAP S4 data models and recommend adjustments to data pipelines.
  • Execute solution and monitor solution performance; proactively flag issues or risks to data integrity.
  • Participates in periodic audits and analyses to ensure accuracy, optimization of systems and reporting

Required Qualifications:

  • Bachelor’s degree in Information Systems, Computer Science, Business Analytics, Accounting, Finance, or a related field.
  • 2+ years of experience with data analytics tools, especially Alteryx and Tableau.
  • Working knowledge of SQL and SAP HANA data extraction.
  • Basic familiarity with accounting, finance, or tax data flows and concepts.
  • Strong problem-solving and communication skills, exceptional attention to detail

Preferred Qualifications:

  • Experience with SAP S4/HANA.
  • Tableau or Alteryx certification.
  • SQL
  • Prior experience supporting data pipelines in a financial or supply chain context.
  • Exposure to continuous monitoring or audit analytics.

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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03.09.2025
BS

Boston Scientific Medical Affairs Specialist III United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Develop and implement global evidence generation strategies to support business objectives, product value and effectiveness. Lead cross-functional teams in designing and executing evidence generation plans. Stay abreast of current and...
Description:

Your responsibilities will include:

  • Develop and implement global evidence generation strategies to support business objectives, product value and effectiveness.

  • Lead cross-functional teams in designing and executing evidence generation plans.

  • Stay abreast of current and innovative analytical methodologies, tools, and applications to ensure state-of-the art evidence generation architecture, platforms, data, and analyses.

  • Collaborate with stakeholders to align and integrate evidence generation activities with overall business objectives.

  • Continuously assess and analyze operations and processes to identify opportunities for alignment, optimization and efficiency improvements related to EGS.

  • Design and deploy tailored tools and frameworks to enable stakeholders to consistently and effectively implement evidence strategies.

  • Implement strategies to identify and eliminate duplicative processes and efforts related to EGS across divisions, regions, and functional areas.

  • Stay current with applicable regulations, industry trends, and best practices in evidence generation to ensure compliance.

Required qualifications:

  • Minimum Bachelor's degree in health science or a related discipline.

  • Minimum 3 years of professional experience in evidence planning, clinical research, or related fields.

  • Proven understanding of medical device total product lifecycle, clinical studies and utility of alternative evidence generation activities.

  • Proven track record of leading and managing global evidence generation projects.

Preferred qualifications:

  • Advanced degree Master’s or a Ph.d in a relevant field (e.g., life sciences, public health, health economics, epidemiology)

  • Previous experience in medical device industry preferred

  • Proven experience in creating evidence strategies within rapidly changing organizational environments

  • Proven ability to build relationships, lead, and educate with excellent interpersonal and influence management skills

  • Preferred Applied Market Analytics knowledge.

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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03.09.2025
BS

Boston Scientific Sr Clinical QA Specialist United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
Participates in clinical project teams, and always influences clinical teams toward a state of inspection readiness. Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical...
Description:

Spencer Gregory Hale

Your responsibilities will include:

  • Participates in clinical project teams, and always influences clinical teams toward a state of inspection readiness

  • Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials

  • Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures

  • Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials

  • Participates in problem-solving with clinical project teams at investigator sites

  • Communicate observations to clinical investigators and clinical program managers

  • Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed

  • Ensures tracking of audit findings

  • Contributes to the development of audit procedures and processes

  • Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives

  • Assists in the preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings

  • Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes

  • Support the Clinical organization in meeting BSC Quality system requirements

  • Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and providing quality input

  • Partner with Clinical to support supplier and BSC-related nonconformances by performing the following activities (NCEP, CAPA, SCARS):

  • Conduct root cause analysis

  • Determine corrective and preventive actions

  • Determine verification of effectiveness actions to support the corrective and preventive actions

  • Support IC CQA portfolio activities and quality system deliverables for IC CQA, including but not limited to quarterly audit schedule updates, management of IC CQA surveillance activities, communication of quality signals to quality leads and clinical leadership, and coordination of clinical and clinical quality QMR deliverables for ICTx and WM.

  • Proactively drive clinical compliance, making data-driven decisions to facilitate process improvement and a proactive quality culture.

  • Participates in the development, implementation, and maintenance of global quality systems. Works to identify ways to improve compliance with regulations and BSC policies and procedures for CQA

Quality System Requirements:

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

  • Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

What we're looking for in you:

Required Qualifications:

  • Bachelor’s degree in science, health, engineering or a relevant field of expertise

  • 5-7 years of work experience with quality systems/controlled processes

  • Previous experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines

  • Strong presentation, communication, and critical thinking skills

  • Strong understanding of Quality Systems

  • Working knowledge of ISO 14155 and GCP

  • Working knowledge of ISO 13485

  • NCEP, CAPA, and Supplier Corrective Action experience

Preferred qualifications:

  • Working knowledge of US and International regulations and standards applicable to BSC

  • Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.

  • Experience working cross-functionally with multiple stakeholders

  • NCEP, CAPA, and Supplier Corrective Action experience

  • Ability to collaborate and influence across multiple, cross-functional teams

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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03.09.2025
BS

Boston Scientific Regulatory Affairs Specialist III United States, Massachusetts, Marlborough

Limitless High-tech career opportunities - Expoint
May work with R&D leadership to define technical roadmaps aligned with business objectives. Drive continuous improvement in engineering processes and methodologies. Collaborate with Regulatory Affairs, Clinical, Quality and Manufacturing teams...
Description:

About the role:

Boston Scientific is looking for a Senior Principal/Fellow Electrical Engineer. You will be responsible for providing electrical and electronic engineering support and expertise in the definition, design, development and test of products in accordance with the Quality system standards, Design Controls and customer requirements. Ensures products are designed to facilitate manufacturability.

Your responsibilities will include:

  • May work with R&D leadership to define technical roadmaps aligned with business objectives.
  • Drive continuous improvement in engineering processes and methodologies.
  • Collaborate with Regulatory Affairs, Clinical, Quality and Manufacturing teams etc. throughout product lifecycle.
  • Participate in executive reviews and strategic planning sessions.
  • Maintains substantial knowledge of state-of-the-art principles and theories in their particular area of expertise.
  • Provides critical design and technical problem resolution.
  • Assume technical lead in the design, development, and testing of complex bioelectronic systems comprised of PCB design, stimulation, power management, wireless communication, and sensing technologies, etc.
  • May lead projects or project teams with moderate resource requirements, risk, and/or complexity.
  • Can work independently within functional / divisional policies while maintaining good communication with functional and cross-functional teams.
  • May help with technical recruitment, training, and ongoing support of staff.
  • Provides technical guidance, training and mentorship to less senior staff contributing to their ongoing development within the company.
  • Provides feedback to the development staff on customer specific enhancements as well as new applications for base product in accordance with Quality System requirements.
  • Ensures new products or product enhancements are designed to facilitate transfer to manufacturing in a timely fashion and in accordance with Quality System requirements. Facilitates the process of transferring products from development to manufacturing.
  • Ensures that engineering testing and documentation is in accordance with regulatory requirements for approval of products by the regulatory agencies of the countries into which the products will be marketed.
  • Works with patent attorneys in documenting innovative ideas, reviewing patent application, and supporting Freedom to Operate Analysis.
  • Converts complex information to compelling business context and advice.
  • Presents convincing arguments for complex ideas and projects at cross-functional meetings in a way that persuades others to agree on recommendation and/or approach, when appropriate.

Required qualification:

  • Bachelor’s degree in engineering or related discipline or equivalent experience. Master’s degree or higher in engineering is preferred.
  • 10+ years’ experience in medical device design or similar products.
  • Experience working under and knowledge of quality systems designed to meet FDA/EU regulatory requirements.
  • Experience and knowledge of pre-clinical testing of medical products.
  • Ability to travel 20% of the time.

Preferred qualifications:

  • Demonstrates strong proficiency in Electrical Engineering, especially in analog circuit design.
  • Ability to adapt and learn quickly leveraging knowledge towards the contribution of projects.
  • Ability to use Microsoft Office tools for documentation, analyzing data, presenting data or ideas, etc.
  • Ability to use Microsoft Excel and other data analysis tools to manipulate and analyze data sets.
  • Competence in the use of Electronics CAD software (Altium) for schematic capture and PCB layout is preferred.
  • Professional, clear verbal and written communications skills required.
  • Ability to work independently or in a team setting as required.

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.

Show more

These jobs might be a good fit

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...
Description:


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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Find your next career move in the high tech industry with Expoint. Our platform offers a wide range of Qa Specialist job opportunities in the United States, Massachusetts, Marlborough area, giving you access to the best companies in the field. Whether you're looking for a new challenge or a change of scenery, Expoint makes it easy to find your perfect job match. With our easy-to-use search engine, you can quickly find job opportunities in your desired location and connect with top companies. Sign up today and take the next step in your high tech career with Expoint.