Regulatory Affairs Specialist Us Market - Cambridge, United Kingdom - Vector Recruitment Limited
Description
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 handson approach to regulatory affairs, not being afraid to get involved with real issues.
- The ability to travel occasionally when required
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