Regulatory Affairs Manager

Location: Irvine, California Salary: competitive
Sector: Regulatory Affairs (RA) Type: Permanent

A small, class II medical device company focusing on surgical tools is seeking a Regulatory Affairs Manager in Irvine, CA. Voted best place to work 3 years in a row, this company offers a great culture, competitive compensation package and is experiencing major growth!

Minimum Qualifications

  • 5+ years of experience in medical device regulatory affairs
  • Experience working in a manufacturing setting
  • Experience managing direct reports
  • Experience with 510(k)s, international and domestic submissions


  • Managing 3-5 direct reports
  • Regulatory submissions
  • Work cross-functionally with other departments, representing regulatory
  • Participate in internal audits
  • Ensuring compliance with regulations and documentation

If interested, please apply! Interviews are taking place the week of April 1st.

Sthree US is acting as an Employment Agency in relation to this vacancy.