At a Glance
- Tasks: Manage quality assurance and regulatory affairs for innovative medical devices.
- Company: Employee-owned leader in drug-free pain relief solutions.
- Benefits: 31 days holiday, hybrid work, pension, and profit sharing.
- Other info: Opportunity for leadership growth in a dynamic environment.
- Why this job: Join a global team and enhance your regulatory knowledge while making a difference.
- Qualifications: Experience in quality management and familiarity with regulatory frameworks required.
The predicted salary is between 35325 - 43175 £ per year.
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
QARA Associate employer: GxPeople Global
As a leading healthcare technology and diagnostics company, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the medical field. Our commitment to professional development ensures that you will have ample opportunities for growth while working on cutting-edge diagnostic devices in a supportive environment located in the UK. Join us to be part of a mission-driven team dedicated to improving patient outcomes through advanced technology.
