Job Description
Remote Regulatory Affairs contractor requires:
- Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
- 5-10 years+ of global medical device regulatory experience
- Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
- Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
- Strong working knowledge of:
- FDA regulations (21 Parts 807, 820)
- FDA guidance documents and eStar requirements
- Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
- Demonstrated ability to work independently as a contractor in a fast-paced environment
- Experience filing medical device submissions in China and other countries
- Experience with audiology devices
- Experience with artificial-intelligence enabled devices
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