Remote Medical Device Regulatory Affairs Expert (FDA 510(k))
Globalchannelmanagement
- Remote job
Globalchannelmanagement is looking for a Remote Regulatory Affairs contractor based in Atlanta, Georgia. The successful candidate should have a Bachelor's degree in engineering, life sciences, or regulatory affairs along with 5-10 years of relevant global regulatory experience in medical devices. The role emphasizes experience with FDA 510k submissions and requires strong technical writing skills. Responsibilities include conducting regulatory reviews and ensuring compliance with FDA, Canadian regulations, and EU MDR standards. #J-18808-Ljbffr Globalchannelmanagement
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## Senior Regulatory Affairs SpecialistApplylocations: Punetime type: Full... ...submission contents.* Lead 510(k) submission, preparation of... ..., Product Development in Medical Devices Industry or equivalent OR 2... ...accommodation for this Office/Remote position.**How we work...Remote workMedical deviceFull timeWork at officeWork visaRelocation package3 days per week- Position Senior Regulatory Affairs Specialist - Durham, NC... ...regulatory applications (510(k), PMA supplements,... ...role within the medical and/or diagnostic device industry. 3+ years of... ...agencies or regions: FDA, EMEA, Canada, LATAM... ...in office and 2 days remote within commuting...Remote workMedical deviceWork at office
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...application process. Regulatory Affairs Manager Full Time... ...of legacy MDD devices, supporting... ...registrations, including FDA 510(k) submissions and... ...subject matter expert and ensure regulatory... ...in the medical device industry,... ...environment and/or remote work. Physical Demands...Remote workMedical deviceFull timeWork at office- ...leading healthcare company is seeking a Manager of Regulatory Affairs based in remote locations. You will develop and execute regulatory strategies, manage FDA submissions, and ensure compliance for innovative medical devices. The ideal candidate has over 8 years of...Remote workMedical deviceFull time
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