Head of Regulatory Affairs in Worcestershire

3 days left

UK, Hereford
£65000 to £70000
Dec 21, 2018
Jan 20, 2019
Contract Type
Full Time
Mary Bolt at CK Clinical is recruiting for a Head of Regulatory Affairs to join an innovative Medical Device company at their site based in Worcestershire on a permanent basis.

The Company:
Our client develop and manufacture high quality and innovative medical devices across the world. They have decades of experience within this industry and work across a wide range of therapeutic areas with a portfolio of brands.

The Location:
The role is based at our client's site in Worcestershire, a county with beautiful countryside and waterways including the Malvern hills and Worcestershire beacon. It could be commutable from Birmingham, South Wales, Cheltenham, Warwick and surrounding areas.

The Role:
The main purpose of the role will be to:
- Direct the regulatory strategy and tasks for all designated projects and accountability for CE Mark technical documentation and liaise with regulatory authorities to ensure continual compliance with International Guidelines and Regulations.
- Monitor and review all company processes, in conjunction with the department manager in order to ensure that they continually conform to the relevant regulations and standards and ensure effective communication between Department and other managers and team leaders in the provision of Quality and Regulatory information and requirements.
- Carry out the duties and responsibilities of a Responsible Person as defined in the Guide to Good Distribution Practice including ensuring that a quality management system is implemented and maintained and ensuring that initial and continuous training programmes are implemented and maintained.

Further responsibilities will include:
- Ensuring regulatory compliance with internal procedures as well as external audit requirements and overseeing the Vigilance reporting function to ensure a safe and effective system is in place for all.
- Implementing a performance management process in line with company policy, throughout the Department.
- Representing the company on the Leadership team on all Quality and Regulatory issues and ensuring effective communication between department and other managers and team leaders in the provision of Quality and Regulatory information and requirements.

Your Background:
To succeed in this role, you will come from a background in:
- Educated to degree level or above in life science or a related field with extensive experience of regulatory affairs within the medical devices industry and line management experience.
- Experience with regulatory affairs across international markets and substantial knowledge of quality systems and auditing.
- Excellent interpersonal skills, problem-solving and leadership skills.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL43737 in all correspondence.