Boston Scientific Principal Regulatory Affairs Specialist 

United States, Minnesota 

833177467

About the role:

As the primary Regulatory Affairs core team member for multiple Class III and Class II medical devices, you will drive regulatory submissions for combination products and contribute to the evolution of therapies that make a meaningful impact on patient lives. You’ll work in a collaborative environment that encourages growth, functional excellence, and partnership across R&D, Clinical, Quality, and Operations.

Your responsibilities will include:

● Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including manufacturing changes, site transfers, and continuous improvement projects.

● Develop U.S. and EU regulatory strategies and prepare submissions for Class III and Class II medical devices, including combination products.

● Create innovative regulatory pathways that support new technologies in collaboration with R&D, Quality, Operations, Medical Safety, and Clinical teams.

● Prepare, coordinate, and compile regulatory submissions such as PMAs, PMA Supplements, IDEs, 510(k)s, EU MDR Technical Documentation, and pre-submissions.

● Collaborate with Clinical Affairs to generate and evaluate clinical and real-world evidence for regulatory submissions and study modifications.

● Partner with international regulatory teams to support OUS registrations and post-market activities.

● Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings.

● Lead interactions with U.S. FDA and EU Notified Bodies to secure regulatory clearance/approval, ensuring alignment throughout the review process.

● Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders.

● Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow-up.

● Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives.

Required qualifications:

● Bachelor’s degree in a relevant scientific or engineering discipline.

● Minimum of 7 years' experience in Regulatory Affairs, or minimum of 5 years' experience with an advanced degree (Master’s or PhD) in a related discipline.

● Demonstrated leadership in regulatory strategy, project planning, and cross-functional execution.

● Experience interpreting global regulatory requirements to ensure alignment with cost, schedule, and performance goals.

● Proven ability to influence and negotiate with global regulatory authorities.

● Proficiency with U.S. and EU medical device regulations, including Quality System standards and clinical investigation requirements.

● Strong understanding of the product lifecycle, including development, clinical studies, manufacturing, and change control.

● Hands-on experience preparing PMAs, PMA Supplements, IDEs, 510(k)s, and EU MDR submissions.

● Excellent analytical, technical writing, and communication skills.

● Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Preferred qualifications:

● Direct experience submitting regulatory filings to FDA, EU MDR, and other global agencies.

● Demonstrated expertise with Class III combination devices in both U.S. and EU markets.

● Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971, and related global standards.

● Ability to work independently and mentor junior regulatory staff.

● Experience serving as the primary regulatory contact for FDA and/or Notified Bodies.

● Proven ability to manage multiple projects and priorities effectively.

● Strong problem-solving mindset with a focus on quality, results, and timely delivery.

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.