QA/RA Specialist

SRG; Epsom; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid working model

31 days holiday including bank

Private medical insurance

Company pension

Profit sharing scheme

Monthly performance-related bonus

On-site parking

Job summary

SRG is seeking a Quality Assurance & Regulatory Affairs Specialist to join a SME Medical Device company on an 18-month maternity cover contract. You will act as the company's appointed Responsible Person (RP) and PRRC, ensuring compliance with ISO 13485, EU MDR, and other global regulatory requirements.

You will collaborate with product development, supply chain, and regulators to support registrations and maintain approvals.

Qualifications

• Experience in Quality Assurance, Regulatory Affairs or Compliance within a regulated environment.
• Strong knowledge of ISO 13485 quality management systems.
• Familiar with EU MDR and medical device regulatory frameworks.
• Experience supporting or leading external audits.
• Experience investigating complaints, non-conformances and CAPA.
• Excellent written communication and stakeholder management skills.
• Eligibility to fulfil PRRC requirements through qualifications or experience.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Act as primary internal and external contact for quality and regulatory matters.
• Support and manage audits, CAPAs, complaints, non-conformances and post-market surveillance.
• Maintain technical files, clinical evaluations and regulatory documentation.
• Work with Notified Bodies and regulators to maintain product approvals and registrations.
• Review changes, labelling and promotional materials for compliance.
• Support supplier quality activities and compliance documentation.
• Conduct internal audits following relevant training and development.

Skills

QA/RA experience

ISO 13485

EU MDR

External audits

CAPA management

Stakeholder management

PRRC eligibility

Job description

General Information

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