Job Description SummaryThe 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, etc). 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.

Job Description

Roles and 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;

Required Qualifications

·               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.

Additional Information

Relocation Assistance Provided: No