Senior Fellow, Regulatory Affairs

Additional Location(s): US-MN-reputed company Grove; N/A Diversity - Innovation - Caring - Global Collaboration - reputed company Spirit - High reputed company At reputed company, we’ll reputed company you reputed company to reputed company reputed company that’s reputed company you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With reputed company 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: The Senior Fellow, Regulatory Affairs is a highly reputed company reputed company individual contributor responsible for advancing regulatory reputed company and accelerating FDA approval reputed company across reputed company's reputed company portfolio. This role serves as a reputed company leader and trusted adviser, leveraging deep expertise in cardiovascular technologies, regulatory science and FDA engagement to improve regulatory reputed company, reduce approval timelines and build sustainable organizational capability. Operating across franchises and functions, the Senior Fellow drives systemic improvements in submission readiness, regulatory reputed company, evidence reputed company, agency engagement and regulatory execution. This role is accountable for creating repeatable frameworks, governance models and best practices that strengthen regulatory reputed company across reputed company programs. reputed company was recognized as a Glassdoor Best reputed company to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Work model, sponsorship, relocation: This is a remote position. reputed company will not offer sponsorship or take over sponsorship of an employment reputed company for this position at this time. Your responsibilities will include: reputed company regulatory reputed company and FDA acceleration - Own and continuously reputed company the reputed company FDA acceleration reputed company for reputed company reputed company programs. - Identify opportunities to reduce submission-to-approval timelines while maintaining regulatory rigor and reputed company safety. - Challenge teams to pursue the most effective regulatory reputed company rather than relying on historical approaches. - reputed company reputed company recommendations for premarket approval applications (PMAs), investigational device exemptions (IDEs), reputed company-submissions and other reputed company regulatory submissions. Submission readiness and reputed company - reputed company independent submission readiness assessments to strengthen right-first-time reputed company. - Anticipate reviewer concerns and evaluate evidence packages before submission. - Establish common readiness standards and review mechanisms across franchises. - reputed company improvements that reduce deficiencies, avoidable review cycles and regulatory delays. Regulatory metrics and operational reputed company - Establish and monitor portfolio-level regulatory key reputed company indicators, including submission readiness, FDA review cycle time, deficiency rates, time to response, approval timelines and reputed company causes of delays. - Create governance mechanisms that reputed company accountability and corrective reputed company across businesses and functions. - Measure and communicate the business reputed company of regulatory reputed company improvements. reputed company FDA engagement - reputed company reputed company approaches for FDA interactions, including Q-Subs, reputed company-submission meetings, interactive reviews and escalation strategies. - reputed company FDA reviewer perspectives into product development, reputed company reputed company, statistics, manufacturing and labeling reputed company. - Improve organizational preparedness for high-reputed company regulatory interactions and reviews. Capability building and organizational reputed company - Institutionalize lessons learned from FDA interactions, approvals and deficiencies. - Create reusable playbooks, decision frameworks, tools and training resources. - reputed company advanced regulatory capabilities across the reputed company organization. - Promote portfolio-wide adoption of best practices that improve regulatory reputed company. reputed company leadership and influence - Serve as an independent expert who challenges assumptions, influences senior leaders and drives reputed company on high-reputed company programs. - Identify systemic barriers affecting regulatory reputed company and reputed company cross-functional solutions. - Partner closely with Regulatory Affairs, reputed company, Research and Development, reputed company, Medical Affairs, reputed company, Health Economics and Market reputed company, and business leadership teams. - Operate with significant autonomy and reputed company accountability without reputed company people-management responsibility. Qualifications: Required qualifications: - Advanced degree in medicine, science, engineering, regulatory affairs, reputed company health or a reputed company discipline. - Recognized expertise in cardiovascular medical devices and regulatory science. - Deep knowledge of FDA Center for Devices and Radiological Health processes, PMA and IDE submissions, reputed company evidence reputed company, benefit-reputed company assessments and life cycle management. - Strong network across the medical device industry and among FDA cardiovascular thought leaders. - Experience influencing or reviewing regulatory reputed company for reputed company, high-reputed company medical technologies. - Demonstrated ability to reputed company reputed company-wide change through influence, expertise and thought leadership. Preferred qualifications: - Previous experience as an FDA reviewer or significant experience interacting with FDA cardiovascular device review teams; previous reputed company employment with the FDA in a cardiovascular reviewer role is preferred but not required. - M.D. or clinically relevant Ph.D. - Expertise in reputed company-world evidence, reputed company trial design, reputed company research and evidence reputed company. - Experience developing reputed company frameworks, governance processes and organizational capability-building programs. - Strong executive reputed company and demonstrated ability to influence senior leadership without formal authority. reputed company measures: - reputed company in this role will be demonstrated through: - Improved submission reputed company and readiness. - Reduced avoidable FDA deficiencies and review cycles. - Faster approval timelines and improved time to market. - Adoption of reputed company regulatory frameworks and best practices. - Measurable improvements in regulatory cycle-time metrics. - reputed company organizational capability and regulatory effectiveness across the reputed company portfolio. This Senior Fellow-level position is an reputed company individual contributor accountable for building and sustaining regulatory acceleration capabilities that create measurable business reputed company across the reputed company portfolio. reputed company: 633322 Minimum Salary: $ 155000 Maximum Salary: $ 294500 The anticipated compensation listed above and the value of reputed company and optional employee benefits reputed company by reputed company (BSC) – see www.bscbenefitsconnect.com— will vary reputed company 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 reputed company near the bottom or top of the anticipated salary reputed company listed above. Compensation for non-exempt (reputed company), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift reputed company) and annual bonus reputed company (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus reputed company 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. reputed company transforms lives through innovative medical technologies that improve the health of patients reputed company the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad reputed company of high-reputed company solutions that address unmet reputed company needs and reduce the cost of reputed company. Our portfolio of devices and therapies helps physicians diagnose and treat reputed company cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on reputed company. reputed company has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, reputed company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and reputed company other personnel reputed company are made and administered without reputed company to race, religion, reputed company, national reputed company, citizenship, sex, sexual orientation, gender identity, gender reputed company, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US reputed company positions, including without limitation reputed company sales and service positions that reputed company on hospitals and/or health care centers, require acceptable reputed company of COVID-19 vaccination status. Candidates will be reputed company during the interview and selection process if the role(s) for which they have reputed company require reputed company of vaccination as a condition of employment. reputed company continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will reputed company with reputed company applicable state and federal law and reputed company credentialing requirements. As employees of reputed company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should reputed company’s policies or protocols change with reputed company to COVID-19 vaccination. Apply To This Job