Pre-Market Regulatory Affairs Manager- Deeside- 55K-65k -PermOur client is a developer, manufacturer and marketer of innovative medical products focused on therapies for the management of...
Pre-Market Regulatory Affairs Manager- Deeside- 55K-65k -Perm
Our client is a developer, manufacturer and marketer of innovative medical products focused on therapies for the management of chronic conditions.
The person will be responsible for the management of global and regional pre-market regulatory projects, including, but not exclusively, new product development, product life cycle and regulatory processes
Duties and Responsibilities
- For medical device products under development, liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation (e.g. for CE marking and 510k) according to the agreed timeline and achieve regulatory clearance
- Review sales training, promotional and advertising material, and labelling components
- Assist with global regulatory processes, such as Change Control, EU Technical File maintenance, GMDN, UDI, etc
NMT 5% of work time.
There may be some business related travel associated with this role dependent on project and / or local market and UK travel associated with this role because some team members are home based and face-to-face contact with line manager and peers may be required.
Attendance of relevant training and development events would be required.
Some destinations may involve overnight stay(s).
- 5-7 year's Regulatory experience in medical devices
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA desirable
- Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC and FDA CFR 820
- Knowledge of compliance with key international standards such as ISO 13485, ISO 14971
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.