Regulatory Affairs Specialist - US Market

Regulatory Affairs Specialist - US Market £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical devices/healthcare sector. The Regulatory Affairs Specialist - US Market will enjoy a varied role, taking a senior role in pre-market submissions pertaining to the appropriate regulatory pathway for new or modified systems. The Regulatory Affairs Specialist will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations, as well as supporting the organization's continued penetration in overseas markets, USA market focus. Thus, extensive experience with FDA and 510 K is essential. The Regulatory Affairs Specialist, will have a strong knowledge of regulatory compliance with a track record of gaining regulatory approvals in various markets; ideally, along with the following experience: Preferably a degree or higher in relevant life science, scientific or engineering-based discipline, however a combination of education and experience may be considered. Experience in the medical device industry Excellent and demonstrable experience with the USA markets and regulatory bodies (FDA). Ability to build relationships between Regulatory Affairs and other areas of the business to work adhesively at all levels. A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.The ability to travel occasionally when required Interested or know someone who might be? Please get in contact with Darren Holmes of Vector Recruitment Ltd

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