Boston Scientific Principal Regulatory Affairs Specialist 

United States, Minnesota 

508071097

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

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.