Principal Regulatory Affairs Specialist

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global leader for over 45 years, we provide high-performance solutions that address unmet patient needs and reduce healthcare costs.

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 support 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 ensure compliance, continuous improvement, and effective regulatory execution.

This role follows a hybrid work model, requiring employees to be in the 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.

Responsibilities

• 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.

Pay

The anticipated compensation range for this role is $102,100 to $194,000. Compensation will vary based on location, experience, education, and other relevant factors. Non-exempt (hourly) roles may also include variable compensation such as overtime, shift differentials, and annual bonuses. Exempt roles may include annual bonuses and long-term incentives, subject to eligibility.

Benefits

Boston Scientific offers a comprehensive benefits package, including core and optional employee benefits. For more details, visit www.bscbenefitsconnect.com.