В международный производитель медоборудования GE Healthcare требуется Regulatory Affairs Leader (RCIS).
Join GE Healthcare as - Regulatory Affairs Leader and you’ll be responsible for leading the overall Regulatory Affairs strategy and direction within the assigned area of responsibility (technical standards, laws and regulations, regulatory programs). You - may lead a team of direct reports to deliver a world-class regulatory service to the business by creating and supporting a regulatory compliant culture and provides advice and counsel to business managers and Quality & Regulatory personnel.
Responsibilities:
- Scan the external environment and work with external associations & global regulatory bodies, proactively adapt regulatory strategies and influence change within areas of responsibility
- Analyze & communicate proposed, new or changing requirements and standards, & lead teams to develop strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements
- Communicate with regulatory authorities within areas of responsibility
- Evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight
- Educate, train, advise & coach company professionals to ensure compliance with RA requirements
- Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility
Qualifications / Requirements:
- Significant - experience in the medical device, product or medical device product regulatory agencies
- Demonstrated knowledge of regulatory issues and experience interfacing with local & internationals regulatory bodies, such as IMDRF, MOH, RZN
- Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
- Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness
- Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals
- Presentation skills with the ability to speak and write clearly and convincingly in English and Russian
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