- Serve as the primary regulatory owner for the PFA portfolio, providing direction on key issues, escalations, and cross-functional decisions
- Provide day-to-day leadership, prioritization, mentoring, and escalation support for regulatory managers and team members
- Establish project priorities, allocate workload, and ensure appropriate regulatory support across the portfolio
- Lead, develop, and mentor a team of regulatory managers and senior individual contributors
- Build leadership depth, succession capability, and regulatory excellence within the PFA regulatory organization
- Support broader electrophysiology regulatory affairs initiatives, including organizational priorities, capability building, and process improvements Internal and external stakeholder collaboration:
- Drive collaboration and alignment with cross-functional stakeholders to integrate regulatory considerations into product and business decisions
- Coordinate strategic alignment across key sites and partners supporting PFA execution
- Lead strategic interactions with FDA, notified bodies, competent authorities, and other regulatory agencies
- Bachelor's degree required or equivalent combination of education and experience
- Minimum of 12 years' experience in regulatory affairs or a combination of regulatory affairs and closely related functions within the regulated medical device industry, including clinical or quality
- Minimum of 5 years' experience in people management, including leadership of managers, senior regulatory professionals, or both
- Demonstrated experience leading global regulatory strategy and execution for complex medical device portfolios
- Extensive experience with regulatory submissions and lifecycle management, including 510(k), IDE, PMA, EU MDR/CE mark, and international registrations
- Proven track record of direct health authority interactions, including leading or supporting regulatory agency meetings and submissions
- Experience managing multiple concurrent regulatory programs or submissions with competing timelines and priorities
- Advanced degree, including MS, PhD, JD, or equivalent
- Prior experience in electrophysiology, ablation, cardiovascular devices, or catheter-based technologies
- Experience supporting integrated portfolios involving disposables, capital equipment, system-level changes, and clinical evidence strategies
- Experience supporting audits, inspections, post-market issues, and sustaining activities
- Strong communication, collaboration, organizational, and influencing skills
- Demonstrated ability to operate effectively in complex, fast-paced, and ambiguous environments Requisition ID: 628715 Minimum Salary: $137700 Maximum Salary: $261600 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).
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. 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.
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.
- Provide regulatory support for audits, inspections, post-market issues, field actions, and other compliance activities
- Contribute to development of best practices, process improvements, and broader regulatory affairs initiatives