Regulatory Affairs/QA Coordinator, Medical Devices

Russell Taylor Group; Wirral; On-site; GBP 30,000 - 35,000; Full time

Job summary

A growing medical devices company in Wirral is seeking a Regulatory Affairs/QA Coordinator. The role involves maintaining the QMS, conducting audits, and responding to regulatory queries. Ideal for candidates with QA/RA experience looking to advance in an SME environment.

Benefits

25 days holiday

NEST pension scheme

6-month probation

Qualifications

• Experience in medical device ISO 13485 setting.
• Experience with CAPA, non-conformances, SOP creation.

Responsibilities

• Maintain and implement ISO 13485:2016 certified QMS.
• Conduct internal audits of the QMS.
• Document customer complaints and product recalls.

Skills

Communication

Interpersonal Skills

Multi-tasking

IT Literacy

Education

Degree in a relevant Scientific/STEM discipline

Job description

Regulatory Affairs/QA Coordinator, Medical Devices

Vacancy Title: Regulatory Affairs/QA Coordinator, Medical Devices

Type: Permanent

Location: Wirral (onsite role)

Salary: £30,000 - £35,000 (depending on experience)

Additional: 25 days holiday, NEST pension scheme, 6-month probation

Our client, a growing medical devices company, is looking to appoint a RA Coordinator who will play an integral role in the development of the QMS & regulatory functions, working cross-functionally across QA/RA/QC teams. This role is ideal for someone with experience in basic QA/RA duties (CAPA, deviations, non-conformances) looking to move into a full-time RA role or continue developing their career in an SME setting, with autonomy to succeed in a positive environment.

The Role includes:

1. Maintenance and implementation of ISO 13485:2016 certified QMS, including writing and updating SOPs and forms.
2. Conducting internal audits of the QMS.
3. Overseeing external audits by current registrar.
4. Documenting customer complaints and product recalls.
5. Implementing and documenting CAPA and non-conformances.
6. Completing management review submissions and design/development documentation.
7. Maintaining medical device files.
8. Responding to regulatory and product queries.
9. Applying Regulation (EU) 2017/746 to various device groups, including technical documentation and post-market surveillance.
10. Liaising with notified bodies and EU Authorized Representatives.
11. Label design and SDS authoring.

The Person:

• Degree in a relevant Scientific/STEM discipline.
• Experience in a medical device ISO 13485 setting, IVD/IVDR, or similar.
• Experience with CAPA, non-conformances, SOP creation, etc.
• High IT literacy, with good written and verbal English skills.
• Strong interpersonal and multi-tasking skills.