EPM is urgently looking for a freelance Regulatory/Clinical Affairs Specialist to support one of our key medical device clients on a 12-month assignment as soon as possible.
Below is a brief overview of the role and its requirements:
- Regulatory Affairs / Clinical Affairs Specialist
- Medical Device Client
- 12-month contract (Likely extension to 24 months)
- Ramp-up project (Start with 20 hours, increasing to full-time by Summer)
- April Start
- Remote role
Must have experience with the following:
- USA market experience (510k, De Novo, PMA)
- Strong interactions with the FDA / Pre-Submissions
- Other regional experience (Canada, UK, EU, etc.)
- Medical Device Experience - across various classes (Advantageous if experience in Pharma)
- Early-stage devices, from viability to market
- Ability to evaluate resources, regulatory pathways, and clinical pathways
This client is one of EPM's largest customers with extensions innovation and products coming to the market. If this role is of interest to you, please apply.
