Valencia Principal Regulatory Affairs Specialist CA 91355

Job description

Additional Location(s): US-CA-Valencia; US-CA-Santa Clara; US-MN-Arden Hills; 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. About the role: At 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. 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. 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. Requisition ID: 637103 Minimum Salary: $ 106800 Maximum Salary: $ 202900 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. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn . 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 t