QARA Associate

GxPeople Global; Epsom; Hybrid; GBP 35,000 - 43,000; Full time

Benefits offered by this job

Hybrid working

Company pension

Private medical insurance

Sick pay

On-site parking

Job summary

GxPeople Global in the United Kingdom (Epsom) is seeking a Quality Assurance & Regulatory Affairs Executive to join the QA/RA team on an 18-month maternity cover contract. The role combines QA administration and regulatory compliance within a medical device environment.

You'll work cross-functionally to maintain ISO 13485 and MDR/CE requirements, with training provided and opportunities to grow into a broader leadership role.

Qualifications

• 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

Responsibilities

• 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

Job 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