QA/RA Specialist

We are seeking a Quality Assurance & Regulatory Affairs Specialist to join a SME Medical Device company on an 18-month maternity cover contract.

This is an excellent opportunity for a QA/RA professional looking to take ownership of quality and regulatory compliance activities while gaining exposure to international medical device regulations and approvals.

The Opportunity

As a key member of the Quality Assurance & Regulatory Affairs team, you will act as the company's appointed Responsible Person (RP) and Person Responsible for Regulatory Compliance (PRRC). Working closely with Product Development, Supply Chain, Manufacturing Partners and Regulatory Authorities, you will play a critical role in ensuring compliance with ISO 13485, EU MDR, and other global regulatory requirements.

This role offers genuine scope to develop your leadership responsibilities while contributing to the growth of an innovative medical device business.

Key Responsibilities

Maintain and continuously improve the Quality Management System (QMS)
Act as the primary internal and external contact for quality and regulatory compliance matters
Support and manage audits, CAPAs, complaints, non-conformances and post-market surveillance activities
Maintain technical files, clinical evaluation reports and regulatory documentation
Work with Notified Bodies and regulatory authorities to maintain existing product approvals and support new product registrations
Review product changes, labelling, claims and promotional materials to ensure compliance
Support supplier quality activities and compliance documentation
Conduct internal audits following relevant training and development
Monitor changes in global medical device regulations and quality standards
Collaborate with product development teams on regulatory strategy and design risk management
Provide guidance and support to the QARA & Supply Chain Administrator

What We're Looking For

Essential

Experience in Quality Assurance, Regulatory Affairs, Quality Management or Compliance within a regulated environment
Strong understanding of ISO 13485 Quality Management Systems
Knowledge of EU MDR and broader medical device regulatory frameworks
Experience supporting or leading external audits
Experience investigating complaints, non-conformances and CAPA activities
Excellent written communication and stakeholder management skills
Eligibility to fulfil PRRC requirements through qualifications and/or relevant industry experience

Desirable

Previous medical device industry experience
Internal Auditor or Lead Auditor qualification
Experience managing quality and/or regulatory teams
Knowledge of FDA, MHRA and Health Canada regulatory requirements

What's in it for You?

Competitive Salary
Hybrid working model: 3 days office / 2 days home
31 days holiday including bank holidays
Additional day off for your birthday
Private medical insurance
Critical illness insurance
Company pension
Profit sharing scheme
Monthly performance-related bonus opportunity
Ongoing training and professional development
On-site parking

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Only candidates based in UK and eligible to work in UK are allowed