GxPeople Global

Quality Assurance & 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 & 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 What's on offer 31 days holiday inclusive of Bank Holidays, plus a day off on your birthday Hybrid working with laptop provided Company pension, private medical insurance and critical illness cover Profit sharing and uncapped monthly commission Sick pay, company events and on-site parking

Are you an experienced regulatory professional looking for your next long-term career move? I am partnering with an innovative, medical technology business to find a dedicated Regulatory Affairs Specialist to join their growing RAQA team on a permanent & 100% remote basis! In this pivotal role, you will champion global regulatory compliance, drive regulatory strategy, and ensure seamless market access for cutting-edge products across multiple regions. What You Will Be Doing: Leading and managing critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k) . Acting as the Person Responsible for Regulatory Compliance ( PRRC ) when required. Producing and maintaining essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation. Guiding cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle. Managing vigilance activities and driving new regional product registrations. What You Bring to the Table: A solid regulatory affairs background within the medical device sector. Proven, hands-on success with EU MDR and FDA 510(k) submissions. Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO (phone number removed) . A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or RA. Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities! If you are ready to take ownership of global regulatory strategies in a forward-thinking, collaborative environment, let s talk!