QA/ RA Associate Director | Competitive | Gateshead, UK

This prestigious, leading, and well-established medical diagnostic company comprises two flagship business divisions that specialise in the design, manufacture and continued support of Haemostasis systems and Clinical Electrophoresis equipment.

The QA/ RA Associate Director will be responsible for ensuring the requirements of the IVD regulation 2017/746 are met as the Person Responsible for Regulatory Compliance. Furthermore, you will act as signatory on the device Declaration of Conformity in line with IVDR requirements ensuring all products are fully compliant with national or regional regulations.

Key responsibilities:
1. To ensure that the requirements of the IVD regulation 2017/746 are met as the Person Responsible for Regulatory Compliance.
2. To act as signatory on the device Declaration of Conformity in line with IVDR requirements.
3. To act as the Qualified Person under the future regulation of medical devices in the UK, and as the Authorised Representative for other Helena companies where required.
4. To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, to include emergency change approval, and rework approval.
5. To act as an approver of risk assessments for products and QMS.
6. To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
7. To act as Management Representative for the site Quality Management System and acting as Audit contact for external bodies.
8. To act as Regulatory contact with MHRA, FDA and the notified body.

Key Skills Required:
• Meets the requirements of Article 15 of EU Regulation 2017/746 to be eligible to perform the PRRC role.
• Knowledge and experience of Quality Management Systems
• Knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
• Understanding of associated standards, regulations and directives such as REACH, CLP, electrical safety standards pertaining to IVD instruments etc
• Knowledge of requirements of Product Technical files for IVD.
• Sound working knowledge of Good Manufacturing Practices, including personnel training skills.
• Design and preparation of SOP’s and Product Risk Analysis (FMEA’s).
• Review and approval of compliance of company production and QC documentation

If you like the look of this role but you’re hesitant to apply because you don’t meet all of the necessary skills, then I’ll encourage you to apply anyway. We’re looking for someone to grow and learn on the job, which can’t really happen if you already know everything.

Tagged as: IVDD, ivdr, medical device regulations, Medical devices