Senior Specialist RA/QA
- Redondo Beach, California
- Regulatory Affairs (RA)
My client is a fast growing medical device company based near Redondo Beach that actively needs a full time Regulatory and Quality specialist with a hybrid background that can lead regulatory submissions while maintaining their quality system.
The company is privately held and leading the way in orthopedic implants. With several new products planned in the coming years they need an individual who can wear multiple hats to lead Regulatory and Quality efforts.
Must have experience for the opportunity:
- Experience with domestic and international submissions( 510(k), CE marking, international submissions)
- Cradle-to-grave experience managing and maintaining a QMS
- Experience leading audits and well versed in ISO 13485:2016
If this sounds like an interesting opportunity for you or something in your network please reach out as I will be contacting top applicants for phone screenings next Thursday and Friday.
Sthree US is acting as an Employment Agency in relation to this vacancy.