Senior Regulatory Affairs Specialist

Additional Location(s): US-MN-Maple Grove

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.       

Senior Regulatory Affairs Specialist
Vascular Therapies Division

About the role:

Join our Vascular Therapies Regulatory Team, where we develop innovative technologies to treat peripheral vascular disease. Our products improve patient outcomes and enhance lives by delivering some of the most advanced and comprehensive therapy solutions on the market.

As a Senior Regulatory Affairs Specialist, you will lead the development and execution of U.S. and EU regulatory strategies to bring and maintain innovative Peripheral Vascular products in global markets. This role supports both new product development and sustaining compliance across a broad portfolio, working cross-functionally with R&D, Clinical, Quality, and Operations as well as international regulatory partners.

As the Regulatory Affairs core team member for Class II and Class III medical devices—including combination products—you will drive critical submission activities and influence the evolution of impactful vascular therapies.

Work model, sponsorship:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Maple Grove, MN 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.

Your responsibilities will include:

● Support development of domestic and international regulatory strategies for Class II and III medical devices
● Coordinate, author, and submit U.S. and EU regulatory filings for new and modified products—including PMAs, PMA Supplements, pre-submissions, 510(k)s, CE Mark submissions under MDR, annual reports, and U.S. clinical investigation submissions
● Support international submissions and registrations in collaboration with Boston Scientific’s global regulatory teams
● Evaluate product and manufacturing changes for regulatory impact and ensure appropriate filing updates
● Represent Regulatory Affairs on cross-functional project teams, including product development, manufacturing processes, and continuous improvement initiatives
● Support regulatory audits as needed
● Maintain a primary commitment to patient safety and product quality by ensuring compliance with Boston Scientific’s Quality Policy and applicable procedures

Required qualifications:

● Bachelor’s degree in a relevant scientific or technical field
● Minimum of 4 years' experience in Regulatory Affairs or a related discipline in the medical device industry (e.g., R&D, Quality, Clinical, Biocompatibility, Labeling)
● Demonstrated experience authoring or supporting a variety of regulatory submissions for U.S. and EU markets, including 510(k)s and MDR technical documentation
● 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
● Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

Preferred qualifications:

● Experience with Class III combination products in both U.S. and EU regulatory environments
● Ability to work effectively in fast-paced, cross-functional environments
● Team player with strong interpersonal and communication skills
● Proven ability to manage multiple projects and competing priorities
● Strong problem-solving skills with a focus on quality, execution, and timely delivery

#LI-Hybrid

Requisition ID: 624469

Minimum Salary: $85000 

Maximum Salary: $161500 

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.