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;
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