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Regulatory AffairsMedical DevicesAssociate
Regulatory Affairs Associate
Irvine, CAPermanent$75,000 – $95,000Posted 1 week ago
About the role
Support regulatory submissions and maintenance for a growing medical device portfolio.
What you’ll do
- Prepare 510(k) and technical documentation packages.
- Maintain regulatory files and product registrations.
- Track changing regulations and assess impact.
- Support post-market surveillance activities.
What you’ll bring
- 1–3 years of regulatory experience, or strong internship background.
- Familiarity with FDA device pathways and EU MDR.
- Excellent attention to detail and organization.
- Life sciences or engineering degree.
Bektin is an equal-opportunity partner. We present every qualified candidate on merit and keep your details confidential until you approve a submission.