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Quality & Regulatory Affairs Leader, RCIS Moscow

2021-05-19 00:40:42
Quality & Regulatory Affairs Leader, RCIS Moscow
Job Description Summary
The Quality Assurance and Regulatory Affairs Leader will ensure product and process compliance to regulatory requirements for the designated product line(s) by managing the quality system design, controls and continuous improvement and establishing best practice standards in the development of new products and post-market support of products. This person will provide advice & counsel to business managers and Quality & Regulatory personnel within the region and global. For premarket/postmarket regulatory activities, this person will work with the RA Manager and a team of Regulatory Affairs professionals and provide subject matter expertise to meet the regulatory requirements in the countries of coverage.
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 cross functional team 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

• Participate in the development and maintenance of a best in class Quality Management System (QMS) and relevant processes to assure product quality and safety.
• Ensure GE Healthcare procedures and proper documentation practices are followed per GE Healthcare QMS requirements.
• Conduct periodically regional QMS and metrics reviews with region top management.
• Coach and mentor functional teams on the development, maintenance and simplification of local procedures.
• Prepare, support and carry out internal/external audits of QMS.
• Support local regulatory authority / notified body inspections as required.
• Support risk management process throughout the product life cycle and providing senior management with key data from RA to help drive decisions.
• Work closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure compliance to applicable regulations and drive product quality in the areas of Design, Service and Manufacturing (when applicable).
• Lead and support continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, and metrics development/implementation.
• As appropriate, recruit, mentor, coach & train indirect reports, as well as distributors on activities within areas of responsibility.
• Proactive member of EMEA QA team taking on role of SME when require.
• Work on Lean projects.

• Identifies, gathers and maintains the information and documents required for the product registration files submitted to regulatory agencies and as per the projects timelines.
• Contributes to writing and editing technical documents.
• Understands and applies regulatory requirements and their impacts for submissions.
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions.
• Supports all assigned new product introductions and country submission projects as applicable.
• Interfaces with the applicable RA representatives to confirm the requirements and the impact of changes in existing products for determination of the need for new/revised licenses or registrations.
• Understands the regulatory affairs activities related to the new product development, to the advertising and promotion and to the post market.
• Participates with the applicable RA representatives, and for countries with license expiration requirements, to the plans, deliverables and timely submission for renewal of license.
• Ensures compliance with premarket product approval requirements
• Performs a broad variety of tasks in support of product and region requirements as assigned by the departmental manager.
• Maintains dashboards of activities and provides data for metrics.
• Participates to the constant improvement of the premarket activities.
• Identify regulatory trends and their implications for GE Healthcare; analyze & communicate proposed, new or changing requirements; communicate and track information for country.

• Bachelor's Degree. Bachelor’ degree in Engineering, Medical Device Technology or Scientific Field preferable;
• Qualified ISO 13485 auditor;
• Minimum 3 to 5 years’ experience in the medical device or pharmaceutical industry, understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry, medical product regulatory agencies;
• Hands-on experience with FDA, QSR, MDD and/or other international quality systems requirements;
• Proven track record in performing external and internal audits;
• Ability to read, analyze and interpret business plans, technical procedures and governmental regulations;
• Good problem identification, multivariable analysis and creative resolution aptitude;
• Proven process development and project management skills;
• 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;
• 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.

Additional Information

Relocation Assistance Provided: No
Moscow Russia
Quality & Regulatory Affairs Leader, RCIS Moscow GE Moscow
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