Regulatory Affairs Specialist jobs in United States, Massachusetts, Marlborough

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.

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.

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.

• 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.

• 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

• 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.

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.

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.

Spencer Gregory Hale

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.