23 Aug REGULATORY AFFAIRS CONSULTANT, MEDICAL DEVICES, CAMBRIDGESHIRE, UK
We have an opportunity for a medical device regulatory consultant to join us on an initial 9 month consultancy project. The role is based in Cambridgeshire but will also have focus on support in the Germany, France and Benelux regions during Brexit.
- Execute regulatory affairs and compliance activities for company product lines in both domestic UK and international markets with primary supporting focus on Germany, France and Benelux.
- Ensure company products and operations comply with applicable international standard requirements including ISO 13485 and EU MDD/MDR requirements.
- Assist in development and execution of regulatory strategies. Review and determine regulatory implications of product, labeling and/or other documentation or design changes.
- Participate on project teams to provide regulatory support and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
- Manage UK RA submissions activity in accordance with business objectives.
- Collaborate with management in establishing departmental strategies and procedures in support of business objectives.
- Participate in UK and wider global project activities with respect to Brexit.
- Degree in a scientific, engineering or technical discipline with 2-3 years experience in regulatory affairs, preferably in medical devices, or equivalent.
- Masters degree in regulatory affairs, scientific, engineering or technical discipline and professional certification is preferred.
- Developed knowledge of international regulations in the areas of the medical devices/technology, ISO 13485 and EU MDD/MDR.
- Experience in microbiology, medical hygiene, sterilization/disinfection and device reprocessing preferred.
- Experience in planning and preparing international regulatory submissions is required.
Salary dependant on experience and negotiable upon application, 9 month + initial consultancy.
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