Senior Regulatory Affairs Manager - Medical Devices

Location
Buckinghamshire
Salary
Competitive salary
Posted
04 Jan 2019
Closes
01 Feb 2019
Ref
J5630685
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
An exciting opportunity for an experienced Medical Device Regulatory Affairs Manager has become available to join a leading Global Pharmaceutical company specialising in a range of products including Class 2 and 3 Medical Devices. The position is based in the Buckinghamshire area but home working is offered. As the Senior Regulatory Affairs Manager - Medical Devices your primary focus will be the management and implementation of Clinical Evaluation processes to ensure all products adhere to the Medical Device Regulations.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Regulatory Affairs Manager - Medical Devices will be varied however the key duties and responsibilities are as follows:

1. You will work at an International Level to ensure all Clinical Evaluation activities are in line with the MDR 745/2017 and MEDDEV 2.7/1 Revision 4. You will author and review clinical evaluation documentation to maintain compliance.

2. As this is a Senior position, you will be expected to perform peer review of a range of complex regulatory documentation and provide clear, constructive regulatory advice and guidance to junior team members as well as company global project teams.

3. You will maintain a state of audit and inspection readiness and support the development and implementation of internal processes.

4. You will develop product registration strategy for new medical device products to ensure that CE marking is achieved and maintained and ensure that Technical Master Files are maintained and reviewed.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Manager - Medical Devices we are looking to identify the following on your profile and past history:

1. Relevant degree at BSc level or appropriate particle experience in Medical Device Regulatory Affairs or Clinical Affairs in addition to experience of authoring Clinical Evaluation documentation.

2. Proven industry experience in the registration and maintenance of products to EU markets is essential to your application and experience of international markets would be a benefit.

3. A working knowledge of Medical Device Regulation 745/2017, MEDDEV 2.7/1 Revision 4 and Clinical Evaluation processes.

Key Words: Regulatory Affairs | Medical Device | Class II | Class 2 | Class III | Class 3 | Medical aesthetics | Ophthalmology | Clinical Evaluation | MDR 745/2017 | MEDDEV 2.7/1 Revision 4 | MHRA | Notified Bodies | TMF | CE Marking

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.