Job Description:
Client is looking for 5+ years of experience in IVD (In Vitro Diagnostics) working in a Regulatory Affairs capacity. Would be working on high level strategy for a new age IVD project. Working closely with the Program Lead and the external collaborator that holds the IP on the drug portion of the IVD to develop strategy to be able to comply with industry standards/FDA/EU regulation. Additional duties in the IVDR space when there is a lull in the project are going to be required so looking for some exposure to IVDR and maintaining all IVD device related requirements. Embedded Software (IEC62304) is a good regulation to be versed in. Ideal candidate has 5+ years of working in life science space, with 2-3 years of IVD / IVDR experience along with experience working on NPD projects supporting a team.
Skills:
- Regulatory Affairs, IVD, IVDR, Flow Cytometry, Embedded Software, Diagnostic
Education:
- Experience outweighs degree
CA (Hybrid): IVD Regulatory Affairs Specialist (236706)
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