Regulatory Affairs Manager

Recruiter
NonStop Recruitment
Location
Durham
Posted
05 Apr 2019
Closes
14 Jun 2019
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time

Would you like to work for a leading diagnostics company?


NonStop Recruitment is currently working with a client who is seeking a passionate individual to join the UK team. Our client is a leading diagnostics company who are always looking to expand their company. Dealing with high quality products to improve the laboratory efficiency and provide fast and accurate solutions for diagnostics and therapy monitoring.


Our client is looking for a Regulatory Affairs Manager to help their team and grow with the company.

Some of the key responsibilities of this job include:
* You will ensure that the IDS product performance characteristics are compliant with FDA and CLSI requirements for IVD devices.
* Technical guidance must be provided on product performance that relate to the regulatory requirements.
* Make sure that US regulatory requirements are clearly identified and implemented throughout the process.
* Manage Regulatory projects effectively by monitoring and settling timelines to achieve aggressive business goals.
* Constructive technical advice and guidance to global project must be given.
* US Regulatory submissions for new IDS products must be prepared.
* Negotiate with authorities such as FDA for marketing authorisation.

Skills and Qualifications
* Science Degree or Higher in Chemistry, Biochemistry, Biomedical Science.
* R&D experience is desirable
* Strong background in the design of development of IVDS
* A strong working knowledge of the performance requirements and characteristics for IVDS.
* Good knowledge of the US registration process particularly 510(k) for In-vitro diagnostic devices.
* Strong oral and written skills
* Ability at working well under pressure and to strict deadlines.
* Work well in a team.


If you feel that you are suitable for the role and interested for the role. Please apply with a word copy of your CV.


Applications are closing shortly.

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