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Salary: USD 102,100 - 194,000 / annual
Boston Scientific seeks a Principal Regulatory Affairs Specialist to join the Interventional Oncology and Embolization division. This role is central to supporting global regulatory compliance across post-market activities including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), recalls, Nonconforming Events and Prevention (NCEPs), and audits.
You will serve as a regulatory affairs specialist collaborating with the Field Action Team on product corrections and recalls, managing communications with internal regulatory partners and external regulatory bodies. Key responsibilities include coordinating and managing PIRs through investigation, documentation, and regulatory authority reporting; developing and monitoring CAPAs to address nonconformances and drive continuous improvement; supporting regulatory activities for internal and external audits; and staying current on regulatory requirement changes to communicate developments to stakeholders.
You will provide regulatory guidance to cross-functional teams on post-market activities and develop training programs on regulatory compliance topics. The role requires deep knowledge of U.S. regulatory requirements and working knowledge of international regulations including EU MDR and other global standards.
Required qualifications include a Bachelor's degree in a scientific or technical discipline, minimum 5 years' experience in Regulatory Affairs and/or Quality within medical devices (with at least 3 years in Regulatory Affairs), in-depth U.S. regulatory knowledge, proven experience managing PIRs/CAPAs/recalls/audits, and proficiency with Microsoft Office, Adobe Acrobat, databases, document control systems, and quality management software.
Preferred qualifications include an advanced degree, strong analytical and problem-solving skills, excellent written and verbal communication abilities, strong interpersonal and collaboration skills, ability to work independently and adapt to changing priorities in fast-paced environments, detail-oriented approach with strong organizational and project management skills, and demonstrated ability to use AI tools to enhance efficiency and decision-making in regulatory research, document generation, data organization, and workflow optimization.
The role follows a hybrid work model requiring in-office presence at least three days per week. Boston Scientific does not offer visa sponsorship for this position.
