QARA Associate

Quality Assurance and Regulatory Affairs Executive Epsom £35,000 £42,-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 and 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 ..... full job details .....