Regulatory Affairs Leader

5 days ago

Pune, Maharashtra, India beBeeRegulatory Full time US$ 1,80,000 - US$ 2,50,000
Lead Regulatory Affairs Professional

This exciting opportunity is for a skilled Lead Regulatory Affairs Professional to join our organization. As the Head of Regulatory Affairs for the Image Guided Therapy Systems (IGTS) Mobile Surgery (MoS) team, you will be responsible for driving significant innovation and providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe.

About the Role:
  • You will develop and implement regulatory strategies and policies for the IGTS MoS business
  • Partner with cross-functional category leadership teams to understand patient and market needs and develop creative strategies for bringing new devices and device changes to market
  • Drive improvement in regulatory aspects of the Quality System, including developing processes and detailing procedures to ensure an effective Quality System
  • Provide mentorship on global compliance, focusing on US, EU, Canada, Japan, and China as well as product registrations and clinical evaluations in accordance with applicable regulations
Requirements:
  • Bachelor's degree or higher in a Life-Sciences discipline or Regulatory Quality Health-related discipline
  • A minimum of 15 years' experience working in Regulatory Affairs within medical device technology environments, with at least 8 years as a functional leader
  • Extensive knowledge of FDA and other regulatory submissions, including pre-submissions, IDE, 510(k), PMA, Technical Files, Design Dossier, and Design Controls
  • Experience with SaMD, AI, and digital health is highly desired

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