Regulatory Affairs Specialist
Due to tremendous growth, Network Partners is looking for a REMOTE Regulatory Affairs Specialist to help continuously develop and enhance our portfolio of industry leading talent.
Network Partners is a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, Packaging Engineering, Labeling, Quality and Project Management. www.networkpartners.com
Network Partners is seeking to hire a REMOTE Regulatory Affairs Specialist to our team that will work with our client partners to ensure the company’s products and processes meet established regulatory standards by identifying shortfalls, developing corrective measures and implementing necessary changes.
In this role you will:
- Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements
- Experience with 510k authoring and submissions
- Initiates and updates regulatory registrations as required and per applicable SOPs.
- Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards
- Provides general support for regulatory team and special projects, as needed