A growing medical device business has an exciting opportunity for a QA/RA Officer to join its team. You will primarily support with regulatory duties, particularly with Technical Files but also support with QA processes. To be considered you will have previous experience in a compliance based role with experience or knowledge of ISO 12485 regulations.
Responsible for the maintenance and update of Design & Technical Documentation Files to demonstrate conformity to essential requirements and essential principles of safety and performance, to ensure compliance to European and Global regulatory requirements.
- To compile and maintain EU Technical Documentation Files as per EU IVDD Directive.
- To contribute towards transitioning from IVDD to IVDR.
- To assist Head of R&D in writing, collating and maintenance of Design Files as per the procedure and in line with ISO 13485.
- To assist technical and regulatory departments in writing, collating and maintenance of the Technical Files.
- To follow and review procedures and work instructions in line with any regulatory requirements, audits and standard practice.
- To check documentation for correctness and regulatory compliance and to assist with technical documentation regulatory compliance enquiries.
- Assistance in quality and regulatory projects, processes and activities.
- To attend team meetings to discuss any arising issues and take minutes of meetings as required.
- To assist in review meetings to plan closure of all audit findings.
- To peer review Design/Technical Files as compiled by other team members.
- To record any projects or notifications which bear impact on Design/Technical files to ensure relevant updates to all packages
- To keep relevant records in the Tracker and Progress reports to show progress.
- To attend technical file reviews, technical standards and other meetings as appropriate.
- To provide administrative support to the QA/RA department.
- Management and collation of all the necessary regulatory documentation required for product registration submissions.
- To carry out any other reasonable tasks as required by the company.
You will have proven experience in the following areas:
- Document Control
- Technical files
- Drafting SOPs and reports
There is the opportunity to work 1 day from home and both full-time and part-time applicants can be considered.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6707
- Posted: 25th June 2021
- Expires: 23rd July 2021