Details:
- Salary: £36,000 - 42,500 - Annum
- Job Type: Contract
- Job Status: Full-Time
- Salary Per: Annum
- Location: South West
- Date: 6 days ago
Description:
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
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