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Talk to Melissa DeSouza, the specialist consultant managing this candidate, located in Toronto

Contact consultant
ttelephone:(416) 367 HAYS (4297)
ffax:(416) 203 1923
Suite 600, 6 Adelaide Street East, Toronto, Ontario, Canada, ON M5C 1H6

Regulatory Affairs Project Manager

Toronto Area

Job type
$100,000 +

• Regulatory Affairs professional with 8 years of progressive local and international regulatory experience in medical devices, IVDs and pharmaceuticals.
• Full Cycle regulatory involvement from product development process to INDs, NDAs/BLAs, and post-marketing activities
• Hands-on experience with a variety of high risk Class III & IV medical devices & IVDs and companion diagnostics.
• Broad experience in project management & writing complex submissions for global regulatory agencies, including PMAs, CE Technical File, Chinese Design Dossier, Canadian Device Licence Application, Japanese Shonin
• Experience in building healthy working relationship with Health Canada, US FDA and other regulatory agencies
• RAC Certification, M.Sc in Bioscience and Regulatory Affairs, B.Sc in Chemical Engineering.