Regulatory Affairs Specialist (Innovation)
Becton Dickinson · 7 Loveton Circle
The apply link worked recently (not employer-confirmed).
Role summary
This regulatory affairs specialist role focuses on guiding in vitro diagnostic devices, automated laboratory systems, and related software through development and regulatory approval. The position involves preparing FDA submissions, EU IVDR documentation, and conducting risk assessments while collaborating across R&D, quality, and business functions. A bachelor's degree in a life science discipline and 2–5 years of direct medical device or diagnostic regulatory experience are required.
What they're looking for
- Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline
- 2-5 years directly related regulatory experience in in vitro diagnostic devices or medical devices
- Strong written and verbal communication skills
- Experience coordinating cross-functional inputs across R&D, Quality, Medical Affairs, and Program Management
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
- Familiarity with SOPs, regulatory procedures, and quality systems such as ISO 13485
- Ability to analyze complex regulatory issues and exercise independent judgment
What you'll be doing
- Serve as regulatory affairs subject matter expert on new product development teams for IVD devices and automated laboratory systems
- Prepare FDA submissions including Pre-IDEs, PMAs, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications
- Lead FDA and EU IVDR submissions and serve as primary contact with FDA and Notified Body review teams
- Identify and address potential regulatory risks within project plans and propose process improvements
- Work cross-functionally with R&D, Medical Affairs, Quality, Marketing, and Program Management teams
Privacy & handoff
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