Principal Regulatory Affairs Specialist

Principal Regulatory Affairs SpecialistAt Boston Scientific, you'll discover a place where you can have meaningful purposeimproving lives through your life's work. In our Rhythm Management (RM) division, we offer innovative solutions for treating irregular heart rhythms and heart failure, while protecting against sudden cardiac arrest. We continue to expand into new geographies and high-growth adjacent markets through cutting-edge technologies.The Principal Regulatory Specialist will be responsible for planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU Notified Bodies, and global regulatory agencies. This role supports worldwide product approvals and registrations, while ensuring continued compliance with regulatory requirements. It also includes change impact assessment, submission of updates, and ongoing maintenance of EU technical documentation.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.Your responsibilities will include:Provide regulatory guidance, training, and mentoring to Regulatory Affairs colleagues and cross-functional partners.Develop global strategies for regulatory approval across all medical device classifications.Coordinate, author, and submit U.S. and EU regulatory filings for new and modified productsincluding 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 partnership with BSC's global regulatory teams.Respond to regulatory and clinical personnel requests related to international clinical investigation submissions.Build and maintain productive relationships with regulatory agency reviewers.Review technical and labeling documentation for regulatory submission readiness and compliance.Evaluate product and manufacturing changes for regulatory impact and ensure appropriate filing updates.Represent Regulatory Affairs on cross-functional project teams, including new product development and continuous improvement initiatives.Support and lead regulatory audits as needed.In all actions, maintain a primary commitment to patient safety and product quality by ensuring compliance with Boston Scientific's Quality Policy and applicable procedures.Qualifications:Required qualifications:Bachelor's degree in a scientific or technical discipline.Minimum of 7 years' experience in regulatory affairs or related field, or 5 years' experience with an advanced degree (Master's or PhD).Proven knowledge of U.S. and EU regulatory requirements for medical devices, including clinical investigations and Quality Systems standards.Experience authoring a variety of regulatory submissions (510(k), PMA, CE Mark under MDR, etc.).Solid understanding of product development, clinical development, manufacturing, and change control.Strong problem-solving and research skills, along with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.Preferred qualifications:Previous experience in the medical device industry, specifically with Class II or III devices.Prior direct experience interacting with the FDA, Notified Bodies, or international regulatory authorities.Ability to work independently and manage multiple complex projects simultaneously.Demonstrated leadership, strategic thinking, and project management capabilities.Experience with capital equipment or software-based medical devices.Strong interpersonal skills and ability to clearly communicate complex regulatory concepts.History of providing technical guidance, training, or mentorship within Regulatory Affairs or cross-functional teams.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 youBoston 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.