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.

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.

• 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

• 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

• 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

• 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.