Principal Regulatory Affairs Specialist

Boston Scientific•Maple Grove, MN

6d•$106,800 - $202,900•Hybrid

About The Position

The Principal Regulatory Affairs Specialist will join Boston Scientific’s Neuromodulation Regulatory Affairs team and develop and execute regulatory strategies for innovative medical devices. The role plans, manages and implements submissions to the U.S. Food and Drug Administration (FDA), European Union notified bodies and international regulatory authorities. It also supports global product registrations, maintains compliance with regulatory approvals and assesses the regulatory impact of product and manufacturing changes. The position works with regulatory agency reviewers and cross-functional teams on submissions, product development, manufacturing changes and quality improvement. It also provides regulatory training and guidance, evaluates product labeling and promotional materials, and supports audits and inspections. The role follows a hybrid work model requiring employees to work in a local office at least three days per week. Sponsorship and relocation assistance are not available for this position.

Requirements

Bachelor's degree.
At least 5 years of experience in regulatory affairs or a related medical device discipline, such as research and development, quality, clinical affairs, biocompatibility or labeling.
Demonstrated experience authoring or supporting U.S. and EU regulatory submissions, including PMA supplements, 510(k) submissions and EU MDR technical documentation.
Proficiency in Microsoft Word, Excel and PowerPoint, and Adobe Acrobat, including preparation of regulatory submissions and presentations.

Nice To Haves

Experience with Class II or Class III medical device regulatory submissions.
Understanding of medical device product development processes and design controls.
Working knowledge of FDA, EU and international medical device regulations.
Ability to manage multiple projects, prioritize competing demands and meet deadlines.
Strong research, analytical and problem-solving skills.
Effective written and verbal communication skills, including technical writing and editing.
Ability to collaborate effectively in fast-paced, cross-functional team environments.
Strong interpersonal skills and a collaborative, team-oriented approach.

Responsibilities

Develop and maintain positive relationships with regulatory agency reviewers through written and verbal communications about regulatory strategies, submission pathways, testing requirements and submissions under review.
Coordinate, compile and submit U.S. and EU regulatory filings for new and modified medical devices, including PMAs, PMA supplements, pre-submissions, 510(k) submissions, annual reports and CE marking submissions under the EU MDR.
Develop and implement domestic and international regulatory strategies for new and modified Class II and Class III medical devices.
Support the implementation and continuous improvement of departmental policies and procedures.
Provide regulatory affairs training and guidance to cross-functional teams.
Represent Regulatory Affairs on cross-functional projects, including new product development, manufacturing process changes and continuous improvement initiatives.
Review and approve product design and manufacturing changes to ensure compliance with applicable regulatory requirements.
Evaluate product labeling, advertising and promotional materials for compliance with global regulatory submissions and applicable regulations, recommending changes as appropriate.
Assess regulatory impacts of product and manufacturing changes and review and approve associated documentation to maintain compliance.
Collaborate with international regulatory teams to obtain and maintain product registrations and approvals in global markets.
Drive continuous improvement of departmental and divisional quality processes through collaboration, best practices and knowledge sharing.
Support regulatory audits and inspections as required.