Principal Regulatory Affairs Specialist

bostonscientific•Maple Grove, MN

32d•$99,100 - $188,300•Hybrid

About The Position

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: Join our Peripheral Interventions team , where we are developing the next generation of cryoablation systems designed to treat abnormal tissue. Our innovative products enhance lives and improve outcomes by delivering one of the most advanced and comprehensive therapy platforms in the market. The Principal Regulatory Affairs Specialist will be responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU Notified Bodies, and supporting global product registrations. This role will directly contribute to new product development , including next-generation cryoablation technologies, and will ensure ongoing compliance through change impact assessments and proactive regulatory engagement. 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 in Maple Grove, MN , 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.

Requirements

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).
Demonstrated leadership in regulatory strategy, project planning, and cross-functional execution.
Strong experience interpreting global regulatory requirements to align 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.
Deep understanding of product lifecycle processes including development, clinical, manufacturing, and change control.
Hands-on experience preparing IDEs, 510(k)s, and EU MDR submissions.
Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Nice To Haves

Excellent analytical, technical writing, and communication skills.
Direct experience submitting to the FDA, under EU MDR, and to other global regulatory bodies.
In-depth knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, and MDCG guidance.
Experience mentoring or guiding junior regulatory staff.
Prior responsibility as the primary contact with the FDA and/or EU Notified Bodies.
Ability to manage multiple projects and competing priorities.
Strong problem-solving skills with a commitment to quality, results, and timely delivery.

Responsibilities

Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including site transfers, manufacturing changes, and continuous improvement initiatives.
Develop regulatory strategies for U.S. and EU Class II medical devices, in collaboration with functional partners.
Prepare and compile regulatory submissions, including IDEs, 510(k)s, EU MDR Technical Documentation, and pre-submissions.
Create innovative regulatory pathways for novel cryoablation technologies, partnering with R&D, Clinical, Medical Safety, Quality, and Operations.
Lead direct interactions with the FDA and EU Notified Bodies, ensuring clear alignment and successful outcomes throughout the submission process.
Support OUS product registrations and post-market activities in partnership with international regulatory teams.
Evaluate design and manufacturing changes for regulatory impact and implement compliant updates to submissions.
Provide timely product and project updates to global regulatory teams and ensure international requirements are communicated to stakeholders.
Build and maintain effective relationships with regulatory authorities through strategic, professional communication.
Apply strong project management, regulatory judgment, and technical writing skills to drive multiple concurrent regulatory initiatives.