Quality and Regulatory Affairs Manager

Posted: 29th September 2017
Closing Date: 31st October 2017

Plasma Biotal are currently recruiting for a Quality and Regulatory Affairs Manager.

You will be able to demonstrate a thorough knowledge and understanding of ISO 13485/9001, continual improvement, internal and external audit procedures and be capable of producing reports and data for Management System Review. Experience and knowledge of root cause investigation and corrective action methodology (CAPA) would be a distinct advantage, especially where previously gained in a manufacturing environment.

A working knowledge in the application of ISO 9001/ISO 13485 Quality Management Systems, FDA Audit approvals or NADCAP-style audit procedures would be highly advantageous in understanding and being able to meet the full requirements of the role.

Consideration will be given to suitable candidates holding either a bachelors degree in a Science or Engineering discipline and/or significant experience within the thermal coatings or similar manufacturing sectors. The position offers the successful candidate an excellent opportunity for personal development for those who wish to progress and expand their knowledge of the medical device sector.

Salary: Competitive and negotiable dependant on qualifications and/or experience.
Pension Scheme: Currently 5% of basic salary.
Profit Sharing Bonus: Profit Related and Discretionary.

Please send a CV with your current and/or expected salary to the following address:

Mr Nick Young
General Manager
Plasma Biotal Ltd.
Meverill Road
Tideswell
Derbyshire
SK17 8PY