Telecommute Senior Regulatory Affairs Specialist

Job ID: Available for Members

Location: California

Compensation: To Be Discussed

Staff Reviewed: Thu, Sep 10, 2020

This job expires in 16 days

Job Category: Healthcare, Information Technology

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A biotechnology company needs applicants for an opening for a Telecommute Senior Regulatory Affairs Specialist.

Candidates will be responsible for the following:

  • Tracking submissions, initiating internal communications and activities
  • Representing Regulatory Affairs on assigned project teams through all phases of product development
  • Attendig product development team meeting

Applicants must meet the following qualifications:

  • Bachelor’s degree in Biology, Chemistry, bio-engineering or related scientific area
  • 5 years of IVD Regulatory Affairs experience to include either 510(k) or PMA Submissions
  • Post-market experience in ISO 13485
  • Experience as the RA representative on project core teams providing active
  • Experience in the balance and application of regulatory requirements
  • Direct and positive experience in communicating with Regulatory Authorities and Distributors