Regulatory Affairs Leader (medical equipment and devices)

компания "ge (general electric company)" ​​​​the regulatory affairs leader is responsible for leading the overall regulatory affairs strategy and direction within the assigned area of responsibility (technical standards, laws and regulations, regulatory programs). he/she 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. ​registration: · bachelorchr(39)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.