Additional Location(s): US-MN-Maple Grove
About the role:We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Oncology and Embolization division. In this role, you will play a pivotal role in supporting global regulatory compliance across key post-market activities, including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), recalls, Nonconforming Events and Prevention (NCEPs), and audits.
You will apply your knowledge of global regulatory requirements while collaborating with cross-functional teams and regulatory partners to support compliance, continuous improvement and effective regulatory execution.
Work model, sponsorship: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:- Serve as a Regulatory Affairs specialist and collaborate with the Field Action Team on product corrections and recalls.
- Manage communications with internal regulatory partners outside the U.S. and external regulatory bodies regarding recalls.
- Coordinate and manage Product Incident Reports (PIRs), including investigation, documentation and reporting to regulatory authorities.
- Develop and monitor Corrective and Preventive Actions (CAPAs) to address nonconformances and support continuous improvement within the divisional Regulatory Affairs group.
- Support regulatory activities associated with internal and external audits.
- Stay current on changes in regulatory requirements and trends and communicate relevant developments to key stakeholders.
- Provide regulatory guidance and support to cross-functional teams on post-market activities.
- Develop and deliver training programs on regulatory compliance topics for internal teams.
Qualifications:Required qualifications:- Bachelor's degree in a scientific or technical discipline.
- Minimum of 5 years' experience in Regulatory Affairs and/or Quality within the medical device industry, including a minimum of 3 years' experience in Regulatory Affairs.
- In-depth knowledge of U.S. regulatory requirements and working knowledge of international regulatory requirements, including the European Union Medical Device Regulation (EU MDR) and other global regulations.
- Proven experience managing PIRs, CAPAs, recalls and audits.
- Proficiency with Microsoft Office and Adobe Acrobat, with the ability to work effectively with databases, document control systems and quality management software.
Preferred qualifications:- Advanced degree in a scientific or technical discipline.
- Strong analytical and problem-solving skills.
- Strong written and verbal communication skills, including technical writing and editing.
- Excellent interpersonal skills and demonstrated ability to collaborate effectively across teams.
- Ability to work independently and as part of a team.
- Ability to adapt to changing priorities and thrive in a fast-paced environment while meeting time-sensitive deadlines.
- Detail-oriented approach with strong organizational and project management skills.
- Demonstrated ability to use artificial intelligence tools to enhance efficiency, accuracy and decision-making, including regulatory research, document generation, data organization or workflow optimization, and a willingness to integrate AI into everyday work processes.
Requisition ID: 633306Minimum Salary: $102100Maximum Salary: $194000The 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.
