Associate Director, RA
On-siteBoston, Massachusetts, United States
Job Summary
Associate Director, Regulatory Affairs on-site responsible for directing submissions to regulatory agencies worldwide and guiding regulatory strategy for products developed, manufactured, or distributed by the company. Leads and develops regulatory professionals, interfaces with agencies and trade associations, and provides executive management with regulatory metrics. Ensures data is identified, obtained, and effectively presented for registrations worldwide; provides regulatory input for product development projects, capital equipment, software (IEC 60601-1), cybersecurity, and AI; maintains knowledge of current and pending regulations; advises senior management on strategies for regulatory approvals; directs staff in implementing regulatory strategy and submissions; supports Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements; complies with FDA and international regulations and company policies; fosters positive and cooperative communication across the organization.
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and work experience.
- 5-7 years of experience in a regulated industry (e.g., medical products, nutritionals).
- 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
Desired Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Previous experience with 510k / PMA submissions.
- Experience working with hardware/ software devices.
- Familiarity with Predetermined Change Control Plans (PCCPs).
- Experience with Medical Devices.
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