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