QARA Associate

CV-Library • Other • 1h ago

Quality Assurance & Regulatory Affairs Executive Epsom | £35,000 – £42,500 | 18-Month Maternity Cover Contract | 37.5 hrs/week | Hybrid (3 days office / 2 days home)

About the role

Our client, an employee-owned medical device company and one of Europe's largest distributors of electrotherapy devices, is looking for a Quality Assurance & Regulatory Affairs Executive to join their QA/RA team on an 18-month maternity cover contract. The company provides drug-free pain relief solutions for chronic pain and childbirth, alongside devices for post-injury muscle rehabilitation.

You'll be a key member of the QA/RA function, working closely with the supply chain manager, product development team, manufacturing partners and distributors to maintain compliance with ISO 13485 and MDR/CE requirements. As part of a global team, you'll have genuine opportunities to build your regulatory knowledge, with training provided as part of the company's continuous learning culture.

What you'll be doing

Day-to-day QA/RA administration and management audits, CAPA, non-conformities, document and records control, complaints, PMS, continuous improvement, supplier records and trend analysis
Contributing to and refining procedures, work instructions, templates and the quality manual to maintain ISO 13485:2016 certification
Working with the QARA team and Notified Body to maintain current certifications and support CE marking, FDA or other market approvals for new products
Preparing and maintaining regulatory files, including Medical Device Technical Files
Reviewing product/process changes, labelling, claims, complaints and promotional materials for regulatory impact
Supporting, and over time performing, internal audits, and representing the QA/RA function during external audits
Resolving quality issues with suppliers, customers or auditors
Taking on line management of a Part-Time QARA & Supply Chain Administrator, with scope to grow into a broader leadership role

What you'll need

Previous experience in a quality management, quality assurance or senior compliance role
Familiarity with regulatory frameworks such as MDR, FDA, Health Canada or MHRA
Strong understanding of ISO 13485, root cause analysis and CAPA management
Experience supporting or leading external audits, and investigating complaints and non-conformances
Strong written communication, organisational and stakeholder management skills
Desirable: medical device industry background, Internal/Lead Auditor qualification, prior experience managing a QA/RA team