Vacancy posted: Tuesday, 3 Jul 2012
An exciting position with a leading Medical Device company has arisen in their Regulatory Affairs team. The regulatory affairs team are responsible for the compliance of onsite products and procedures to ensure they meet industry standards. The purpose of the role is to support the team’s objectives with regards to clinical studies and industrial regulations. Applications are encouraged from experienced QA professionals with auditing experience looking to develop a career in Regulatory Affairs.
Candidates from a quality background should have a certificate in ISO9001 auditing, ideally have some experience in clinical studies/project master files and a background in ISO13488 or ISO9001.
The role involves:
- Checking design history files.
- Performing Gap analysis
- Updating and maintaining standards and regulations.
- Working to ICH and GCP guidelines.
The ideal individual will possess excellent attention to detail, be well organised, can work on their own initiative and genuinely interested in developing a successful career in RA within a market leader in their field.
Please apply online or contact Darren on 0141 331 9070 in the first instance.