GE Healthcare is looking for a Regulatory Affairs Leader (RCIS).
Registration:
- Bachelor's Degree;
- Minimum of 5 years’ experience in the medical device or pharmaceutical industry or medical product regulatory agencies;
- At least 2 years experience with GE, including training and coaching of team members;
- Demonstrated ability to coordinate cross-functional, cross-business teams;
- Demonstrated knowledge of regulatory issues and experience interfacing with local & internationals regulatory bodies, such as IMDRF, MOH, RZN etc.;
- Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals;
- 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;
- Excellent verbal and written communication;
- Presentation skills with the ability to speak and write clearly and convincingly in English and Russian;
- Ability to influence and make recommendations at all levels of the company.
Qualifications:
- Strategic goals;
- 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;
- Effective report, business correspondence and procedure writing skills;
- Presentation skills with the ability to speak and write clearly and convincingly in English and Russian;
- Strong computer skills;
- Ability to communicate fluently in English;
- Be positive, open-minded, strong team player;
- Ability to handle and work with tight and pressured deadlines.