Principal Regulatory Affairs Specialist

Additional Location(s): 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:
We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division. The successful candidate will play a pivotal role in ensuring global regulatory compliance across various domains, including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), Recalls, Nonconforming Events and Prevention (NCEP’s), and Audits. This position requires a thorough understanding of global regulatory requirements and the ability to effectively collaborate with cross-functional teams.

Your responsibilities will include:

• Work as the PI Regulatory Specialist interacting with the Field Action Team for product corrections and recalls
• Manage communication with internal OUS regulatory partners and external regulatory bodies for 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 non-conformances and ensure continuous improvement for the PI Regulatory group
• Assist in management of regulatory activities associated with internal and external audits
• Stay current with changes in regulatory requirements and trends to communicate to relevant stakeholders
• Provide regulatory guidance and support to cross-functional teams for post-market activities
• Develop and deliver training programs on regulatory compliance topics to internal teams

Required qualifications:

• Bachelor’s degree in a scientific or technical discipline; advanced degree preferred
• Minimum of 5 years of experience in Regulatory Affairs and/or Quality, with at least 2 years' experience working in Regulatory Affairs, preferably in the medical device industry
• In-depth knowledge of US regulatory requirements with a preference of international regulatory requirements, including EU MDR, and other global regulations
• Proven experience in managing PIRs, CAPAs, recalls, and audits
• Proficiency in regulatory submission software and databases

Preferred qualifications:

• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Candidate must be adaptable to changing priorities, thrive in a fast-paced environment under time sensitive deadlines
• Detail-oriented with strong organizational and project management skills

#LI-Hybrid

Requisition ID: 602161

Minimum Salary: $99100 

Maximum Salary: $188300 

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.

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 you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

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 identify, 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.