Associate Director Regulatory Affairs
A leading global medical device company is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategy and execution for a rapidly expanding portfolio. This role provides senior regulatory leadership across new product development, clinical strategy, submissions, approvals, sustaining activities, and global expansion. The ideal candidate brings deep experience navigating complex regulatory pathways and managing high‑impact programs in fast‑paced environments.
The Associate Director will be responsible for…
- Leading global regulatory strategy across the full product life-cycle
- Overseeing preparation and submission of major regulatory filings (510(k), IDE, PMA, EU MDR/CE mark, international registrations)
- Assessing regulatory risks, timelines, and trade‑offs to inform business decisions
- Managing multiple concurrent regulatory programs with competing priorities
- Providing leadership, direction, and mentorship to regulatory managers and senior contributors
- Driving cross‑functional alignment with R&D, clinical, quality, operations, and program teams
- Leading interactions with FDA, notified bodies, and other regulatory authorities
The Associate Director should have the following qualifications:
- Bachelor's degree in a scientific, engineering, or related field
- 8+ years of regulatory affairs or closely related experience in the medical device industry
- 3+ years of people leadership experience, including managing managers or senior regulatory professionals
- Proven experience leading global regulatory strategy for complex device portfolios
- Extensive experience with 510(k), IDE, PMA, EU MDR/CE mark, and international submissions
- Strong communication, collaboration, and organizational skills
- Ability to operate effectively in complex, fast‑moving, and ambiguous environments
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