Regulatory Affairs Specialist

Regulatory Affairs Specislait

My cleint is a world class, award winning Medical Device company based in Cambridge. They are currently looking for an experience Regulatory Affairs Specialist.

Responsibilities:

• Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• Preparing document packages for regulatory submissions
• Keeping abreast of regulatory procedures and changes
• Reviewing proposed product changes for impact on their regulatory status
• Communicating with regulatory and governmental agencies
• Reviewing proposed labelling, promotion and advertising material for its compliance with applicable global regulations
• Responding to requests from foreign government and/or distributors as needed.

My client is a high growth company and the positions evolve so they are looking for an individual willing to turn their hand to anything within the regualtory affairs remit and develop within the role.

Required experience and skills:

• Experience in the medical device industry
• A strong attention to detail and the ability to multi-task and balance competing priorities
• The ability to build relationships between Regulatory Affairs and other areas of the organisation and to communicate effectively at all levels
• A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.
• A thorough and sound working knowledge of regualtory compliance in Europe, USA, China and Japan and have a track record of successfully gaining regulatory approvals in various markets

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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