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FDA Regulatory Associate Attorney

BCG Attorney Search Jan 06,2020 Nov 08,2019 Location USA San Francisco CA
This job is expired...

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Attorney

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

1-5 yrs required

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San Francisco office of an AmLaw firm seeks FDA regulatory associate attorney with 2-3 years of experience. The candidate will work on medical device regulatory matters. Must preferably have experience researching FDA medical device regulatory issues; providing advice on regulatory pathways; drafting regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); preparing responses to FDA premarket review; and posting market compliance questions and deficiencies. Scientific, health or biotech background is preferred. Experience at FDA is a plus. Must have interest in handling FDA medical device matters (scientific, health or biotech background preferred). California Bar membership in good standing is required.

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