Regulatory Affairs Manager - Medical Devices

2 days left

Search Consultancy
24 Jul 2019
21 Aug 2019
Contract Type
Full Time
Regulatory Affairs Manager - Medical Devices

Are you looking for a challenging, and worthwhile career opportunity where your contributions will help to accelerate healthcare technology and make a difference in people's lives?

As a Regulatory Affairs Manager you will be responsible for managing global product registrations projects in accordance with country-specific requirements and internal systems.

Other duties will include:

* Management of a small team
* Determining regulatory pathways for product registration in various global countries
* Managing and assisting with the writing and preparation of technical documentation to meet regulatory submission requirements e.g. CE submissions and US FDA 510k submissions.
* Development and management of Post Market Clinical Follow Up (PMCF) projects as required.
* Responsible for compliance and diligence of product technical product files
* Determine and maintain regulatory intelligence information and update quality management systems as required in accordance with this information.
* Provide expert advice in Medical Device Regulations (MDR).

I am interested in speaking to individuals who have a degree or equivalent qualification in a science based subject. It is essential that you have experience on product file management within medical devices. Knowledge and understanding of EU Medical Device Regulations (MDR), FDA regulations including 21 CFR 820, EU Medical Device Regulations.
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.