Connecting...

Directory of Regulatory

A Medical Device company is looking for help with multiple 510(k) submissions and maintenance for multiple products that have been released in Japan and are being introduced to the US market. Their products consist of mostly Class II IVD diagnostics automated immunoassay devices. This position will be reporting to the VP of Regulatory Affairs and managing a few people.

Requirements:

  • Multiple years experience in Medical Device Regulatory Affairs
  • At least 3 years experience in IVD Diagnostics
  • Background in Biology, Chemistry or Microbiology
  • Basic understanding of immunochemistry and HPLC chemistry
  • Previous experience in submitting and maintaining 510ks with a preference for experience in PMA
  • Strong communication and interpersonal skills

If interested please apply through this portal as soon as possible. We are looking to have interviews as early as next Monday. They have a great deal of flexibility for the right candidate.

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