Regulatory Affairs Specialist – IVD REF: 862
This is a senior, specialist opportunity for an RA professional with a background in precision medicines. This is a long-term client engagement with a global biopharmaceutical company, based in the US or EU.
- Experience working on both therapeutics and in vitro diagnostic medical devices (IVDs) in the US and EU
- Experience in seeking clinical trial or marketing authorization for markets including US, EU, AU, Japan, and emerging markets eg BRIC
- Working knowledge of Software as a Medical Device (SaMD) and related regulatory strategies
- Prior experience as Lead on development teams (devices and therapeutics).
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- Contract Type:
Flexible; US based
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