Role: Senior Director/Director of Regulatory Affairs – Medical Device (Greater Boston, MA)

A growing medical device client is looking for a Senior Director/Director of Regulatory Affairs to lead their regulatory efforts for Class III devices. The role involves managing FDA and international submissions, guiding product development teams, and ensuring compliance with regulatory requirements.

Key Responsibilities:

• Lead FDA submissions (PMA, IDE, 510(k)) and regulatory approvals.
• Manage and mentor a regulatory affairs team.
• Collaborate with Product Development, Quality, and Engineering to ensure compliance.
• Serve as primary contact for FDA inspections and submissions.
• Develop and maintain regulatory processes for medical device reporting.

Requirements:

• 10+ years of regulatory experience in the medical device industry, including Class III devices.
• At least 5 years of management experience.
• Strong track record in FDA submissions and approvals.
• Excellent communication skills.
• Minimum of BS in Engineering, Life Sciences, or related field (advanced degrees preferred).

If interested, please send your resume to r.burton@hwthree.com