Head QA/RA - Medical devices

Head of QA and RA (Medical Device) - Yorkshire - GBPcompetitive

My client, a medical device company based in Yorkshire and is at the leading edge of technology and has won many awards for innovation. They are currently recruiting for a Head of QA and RA to lead all aspects of Quality and Regulatory within the group. Reporting the CEO, you will be responsible for developing the strategy contributing to the formulation, development, implementation, and administration of Company policies and business goals.

Regulatory affairs specialist Responsibilities:

- Own the QMS, Validation and the Regulatory direction and delivery for Class III devices

- Lead and direct the company to ensure data/evidence is available at the right time of submission

- Review, challenge and update the QMS ensure compliance to regulatory and 13485 changes

- Ensure complaints and adverse incidents are accurately recorded, acted on and completed

- Develop, manage and maintain the company's device family technical files

- Provide expert advice and input to NPD, Submissions, renewals and business direction

- Full JD available

Essential and personal Experience

- Must have previous experience of being a senior manager within a medical device company delivering across Quality and Regulatory Functions ideally within Class IIb, IIa or III devices.

- Ability to build and work within a team, Liaise with notified bodies

- An aptitude for the critical assessment of QMS, scientific reports and protocols.

-Degree qualified - preferably Engineering or Scientific

If you believe you hold the relevant background experience and looking for a fantastic opportunity to join a growing Medical device company and in return they are offering a competitive package, Salary, Car Allowance...

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.