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
