Regulatory Affairs Associate
If the sound of 510(k) doesnt scare you…If “ISO 13485” feels like a second language…If you love the thrill of helping innovative medical devices cross the regulatory finish line…Then you might be exactly who our client is looking for.The Mission?Join a team on the cutting edge of orthopaedic innovation! - Youll be the bridge between big ideas and real-world, regulatory-approved solutions.What youll actually do:Craft global regulatory strategies
Own FDA, ISO, and CE compliance
Build 510(k)s, PMAs, and other submission beasts
Be the go-to with agencies and auditors
Keep tabs on all post-market surveillance and quality systems
Use your clinical + technical brain to shape future product designs
Join a fast-moving, forward-thinking team that is passionate about what they do!Youll need:✅ Three + years of solid regulatory experience (ideally med device)✅ Deep understanding of FDA + ISO frameworks✅ Confidence with submissions and global reg strategy
Location: Flexible hybrid setup - (Would consider fully remote for the right candidate)
Information :
- Company : Medical Engineers Recruitment
- Position : Regulatory Affairs Associate
- Location : Worcester, Worcestershire
- Country : GB
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Post Date : 2025-06-18 | Expired Date : 2025-07-18