Job Ref: 214450825

Date: 2021-08-17 12:11:19

Apply Now

We are a well established leading Medical Device company and due to our continued growth have an exciting opportunity for a Regulatory Affairs Engineer to join the team.

As our new Regulatory Affairs Engineer, you will be responsible for the maintenance and development of our technical files and will assist in the transition to MDR. You will be involved in Post Market Surveillance, Customer Complaints and CAPA reporting.

Essential Skills

Proven Regulatory Affairs Experience within the Medical Device sector.

Experience of interpreting and implementing standards and regulations essential.

Broad background in quality and regulatory compliance of systems and products essential.

Broad background in electro/mechanical products essential, along with an understanding of the impact of regulatory requirements.

Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR highly desirable.

Experience of medical device manufacturing and medical standards desirable.

This is a site based position.

If you have the experience necessary to be successful in this role, please get in touch

Apply Now