Medical Device Auditor
Russell Taylor Group has a fantastic opportunity for a Medical Device Auditor (active/Non Active)
To join a world leading testing and product certification company. Provides peace of mind that products are safe, reliable and compliant by providing testing, product certification, knowledge services and training to a range of industries covering the Aerospace, Defence, Electronics & Consumer, Machinery, Marine, Medical, Rail and Telecommunications sectors.
Working as part of a team of medical specialists, the role will entail conducting regulatory audits and reviewing documentation to support CE marking, worldwide regulatory regimes and quality management system certification to enable manufacturers, importers and distributors to meet their compliance obligations and to help them to develop safe and effective devices and to enable them to sell their devices around the world.
This role would suit an experienced auditor from the medical device industry with a strong working knowledge of active/non active medical devices.
Duties and Responsibilities:
- On-site auditing to European and worldwide regulatory requirements including ISO 9001, ISO 13485, MDSAP and the Medical Device Directive.
- Technical documentation file review
- Providing technical support to the team
- Promotion of the business through seminars, webinars, articles, training courses and trade shows.
- Degree in a relevant scientific discipline
- Experience of working with active/non active medical devices
- A thorough understanding of regulatory requirements including ISO 9001, ISO 13485, MDSAP and the Medical Device Directive.
- Willing to undertake frequent travel across the UK and Ireland, as well as internationally as required
- Logical and methodical
- Ability to work under pressure with a commitment to get the job done.
- Excellent verbal and written communication skills
- Full and valid driving licence
- Experience as an external lead auditor assessing companies against the requirements of the EU Medical Device Directive.
- Knowledge of the new Medical Device Regulation
- Previous regulatory auditing experience
- Second language