Healthcare jobs
OperationsRemote
Senior Regulatory Affairs Specialist
Natera Remote Posted Sep 30
About the role
This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.
What you'll do
- Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements.
- Provides guidance on requirements to product development teams.
- Develops strategies for submissions to FDA and other regulatory agencies.
- Provides risk assessments and regulatory options.
- Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP);…
- Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
What you'll need
Natera lists the full requirements on its posting.