Principal Regulatory Affairs Specialist

Principal Regulatory Affairs SpecialistAt Boston Scientific, you'll discover a place where you can find meaningful purpose by improving lives through your work. We continue to innovate in key areas while expanding our products into new geographies and high-growth adjacent markets.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.The Principal Regulatory Affairs Specialist will join our Neuromodulation Regulatory Affairs team and play a key role in developing and executing regulatory strategies for innovative medical devices. This individual will be responsible for planning, managing and implementing regulatory submissions to the U.S. Food and Drug Administration (FDA), European Union (EU) notified bodies and international regulatory authorities.This position will also support global product registrations, maintain compliance with regulatory approvals and assess the regulatory impact of product and manufacturing changes. The ideal candidate will bring strong regulatory expertise, strategic thinking and cross-functional collaboration skills to help advance technologies that improve patients' lives.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:Serve as a company representative, developing and maintaining positive relationships with regulatory agency reviewers through written and verbal communications regarding 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 premarket approval applications (PMAs), PMA supplements, pre-submissions, 510(k) submissions, annual reports and CE marking submissions under the EU Medical Device Regulation (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 the regulatory impact of product and manufacturing changes, including reviewing and approving 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.Required qualifications:Bachelor's degree.Minimum of 5 years' 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, PowerPoint and Adobe Acrobat, including preparation of regulatory submissions and presentations.Preferred qualifications: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.Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.