Description
My client is a large medical device company in the south west that is now looking for an RA/QA Specialist to join their team. £40-45,000.- Assure the maintenance, continuance and control of a Quality Management System according to international standard ISO 13485, European Medical Device Directive (MDD) 93/42/EEC, and corporate guidelines/policies in the UK
- Assure an effective, consistent and reliable forward of information in terms of product surveillance on the local market in accordance with legal requirements (e.g. MDD) and procedures.
- Surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of companie's business.
- Represent the Quality Assurance and Regulatory Affairs Functions within UK.
- Implementing, development, maintenance and control of a Quality Management System according to ISO 13485 and corporate guidelines/policies.
- Manage customer complaints handling.
- Support instructed actions e.g. product blockings, recalls, provide field safety notices.
- Responsibility for product registration on the market in accordance with local legal requirement; main contact for the UK competent authority and responsibility for the maintenance of the business in the local market regarding authority's demands.
- Initiation of internal and external audits; also cooperation within an internal auditor team coordinated by headquarters.
- Continuous communication with QA/RA EMEA team.
- Advise general management and work close together with other departments of ZOUK to support the business in the county as far as principles allow.
- Involvement in special projects and special duties like (re-)validation of technical systems and procedures.
- Represent companies interest in national associations or similar organizations. Involvement in task forces of such organizations if necessary.
Essential Requirements;
- Knowledge of UK medical device regulations
- 2-3 years experience in a similar role within a Medical Device company.
- Ability to function independently without extensive oversight and extensive local quality organization
- Experience in leadership and teamwork
- Ability to prepare high quality, clear communication materials tailored to the appropriate audience
- Discretion and confidentiality
- Experience in Quality Management and verifiable experience in Quality Assurance, engineering or validation
- Qualified auditor/lead auditor preferred
If you believe you have the correct experience then please send me your CV and I will be in touch shortly.