On behalf of my client, a global company in the science industry, I am recruiting for a Senior Regulatory Affairs Specialist, EMEA. In this role you will report to the Regulatory Affairs Manager and you will assist with the running of the Regulatory Affairs team by ensuring that the EMEA registrations, regulatory communications, Post Market Surveillance, Distribution Channel Management and EC Authorised Rep functions of the RA team are effective and the required regulations are implemented.
Candidates with the following background and experience are invited to apply:
- Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable
- Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.Knowledge of requirements in other jurisdictions where required.
- Knowledge of medical device quality standards/practises or similar regulated industry.
- Good communication and inter-personal skills.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft®
- Proven organisational skills.
- High self-motivation.
- Approved External Auditor.
- Willingness and availability to travel on company business.
For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671.