Principal Regulatory Affairs Specialist

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.       

About the role:

The Principal Regulatory Affairs Specialist will lead the development and execution of U.S. and EU regulatory strategies to bring innovative Peripheral Vascular products—particularly drug-eluting devices—to market. This role supports both new product development and ongoing compliance for a broad vascular portfolio, collaborating with cross-functional teams and international regulatory partners to ensure alignment and success.

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.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

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.

Qualifications:

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.

Requisition ID: 618096

Minimum Salary: $99100 

Maximum Salary: $188300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.