Job Title: Regulatory Affairs Manager - In-vitro Diagnostics

Posted: 2021-06-09 10:01:40

Do you have expert knowledge within the in vitro diagnostics industry and want to be at the cutting edge of scientific advancement?  Then please read on….

 

Our international client is a molecular diagnostics company which develops and manufactures accurate genetic products / services and who works in partnership with global leaders in DNA technology to progress diagnostic science.    They are looking to recruit a Regulatory Affairs Manager - In-vitro Diagnostics to their team.

 

You will support the effective management of the company’s regulatory affairs policy in order to achieve its global strategy.  Managing a small team, you will liaise with multi-disciplinary teams both internally and externally, as well as the senior management team.  You will lead on all aspects of technical files/medical device files for the product range so your expert knowledge in IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities will be essential.  As will your experience of country approval (eg. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support.

 

To be successful you will have a relevant degree in Life Sciences, preferably in genetics or molecular biology, together with demonstrable experience of working within the MDD and/or IVDD regulatory affairs arena.  Leadership and management skills together with knowledge of ISO 13485 and IVD Directive requirements is essential.

 

For further information please contact Andy Cuthbert on 01606 818295 or email ac@entrustrs.com


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