- Experience Level
- Experienced (non-manager)
Quality Manager (Regulatory Affairs Associate)
Location: London (and remote, where necessary)
About the client
My client is working to solve the problem of inaccessible, unaffordable fertility care. Their product is a fertility treatment based on Intracervical Insemination (ICI). It’s safe, clinically-validated and effective. Most importantly, it’s affordable and inclusive.
They’re on a mission to democratise access to fertility care, and they’re looking for their first regulatory affairs hire; someone to define and lead their regulatory pathway; someone as obsessed with their mission as they are.
We’re looking for a Quality Manager to join their venture-backed, early-stage fertility startup. You will be defining and designing their QMS and Regulatory Strategy right from the very beginning.
You will work alongside the COO to manage and develop the QMS, and guide the company through an EU MDR (Class IIa) and FDA 510k (Class 2) certification process.
Early on, you’ll wear a lot of hats; from strategy sessions to QMS fixes, nothing is off the table. But their promise to you is to empower you to own the regulatory function in their fast-paced startup.
● QMS management and development
● Internal QMS Audits
● External QMS Audits
● Technical file updating and maintenance
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