Director of Regulatory Affairs
On-site · Boston, Massachusetts, United States
Job Summary
Director of Regulatory Affairs overseeing regulatory strategy, submissions, and compliance for medical devices. Lead development and implementation of regulatory strategies, manage submissions (510(k), PMA, Technical Files) to global agencies (FDA, EMA, TGA), ensure ongoing compliance with ISO standards and FDA regulations, monitor regulatory developments, manage risk, and lead a high-performing regulatory affairs team. Collaborate cross-functionally with R&D, quality, clinical, and marketing to integrate regulatory requirements into product development, launches, and post-market activities. Requires extensive experience in regulatory leadership, deep knowledge of global requirements, successful regulatory submissions, and strong leadership and communication skills.
Required Qualifications
- Bachelor’s degree in life sciences, engineering, or a related field; advanced degree (e.g., Master’s, PhD) or regulatory affairs certification (RAC) preferred
- Minimum of 10 years of experience in regulatory affairs within the medical device industry, with at least 5 years in a leadership or management role
- Deep understanding of global regulatory requirements, including FDA, EU MDR, ISO standards, and other international regulations
- Proven track record of successful regulatory submissions and approvals for medical devices
- Strong leadership, communication, and interpersonal skills, with the ability to build effective relationships with regulatory authorities, cross-functional teams, and external partners
- Excellent analytical and problem-solving abilities, with a strategic mindset and attention to detail
- Proficiency in regulatory software and tools, as well as familiarity with electronic submission processes and regulatory information management systems
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