Quality Assurance & Regulatory Affairs Specialist - #1784293

Join Genedrive as a Senior Quality Assurance & Regulatory Affairs Specialist! Shape the future of global medical diagnostics while driving compliance excellence in a dynamic and innovative environment.

QA/RA SpecialistManchester, M13 9XX

• Full-time, 12-month contract (Maternity Cover)
• £35,000 - £45,000 per annum
  
  

Please Note: Applicants must be authorised to work in the UK

Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a strong collaborative culture and a mission to make diagnostics more accessible and efficient, Genedrive is leading advancements in point-of-care testing on a global scale.

The Role

Genedrive is seeking a knowledgeable and driven Senior Quality Assurance & Regulatory Affairs Specialist to join their QA/RA team on a 12-month maternity cover contract.

Key Responsibilities

• Lead and support continuous improvements within the Quality Management System (QMS)
• Collaborate with all departments and external stakeholders to maintain regulatory compliance
• Provide QA/RA expertise throughout product development and change control processes
• Guide risk management and post-market surveillance activities
• Conduct root cause analyses for CAPA investigations
• Review SOPs, software development documents, and regulatory submissions
• Deliver training to ensure quality and regulatory understanding across the business
• Perform internal and supplier audits and support external inspections
• Validate QMS-related software and manage eQMS platforms
• Assist in compiling and maintaining technical and regulatory documentation
  
  

Benefits

At Genedrive, you’ll be part of a passionate and expert team, making a tangible difference in global healthcare.

• Contribute to life-changing diagnostics
• Gain exposure to international compliance and regulatory frameworks
• Work in a supportive, growth-oriented culture
• Hybrid working potential
• Based in Manchester’s innovation hub with excellent on-site facilities
  
  

The Ideal Candidate

About

You are a proactive and experienced QA/RA professional with a background in medical devices or IVDs, ready to lead with precision and confidence. About you:

• Degree-qualified in a science or engineering discipline
• Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector
• Solid understanding of ISO 13485 and ISO 14971
• Experience with internal/external audits and training delivery
• Excellent analytical, organisational, and communication skills
• Comfortable working independently and within cross-functional teams
  
  

Desirable

• Knowledge of IEC 62304, ISO 60601, and global radio regulations
• Experience with global medical device regulations particularly UK, EU and USA
• Familiarity with the commercialisation of IVD products
• ISO 13485:2016 Lead Auditor training
  
  

This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now!

How To Apply For The Role

If you have the skills and experience required for this position, click "apply" today and check your inbox for an email providing more information on how to complete your application and provide any other supporting documents.

You must be authorised to work in the UK. No agencies please.

Other suitable skills and experience include Quality Assurance Manager, Regulatory Affairs Specialist, QA/RA Manager, Medical Device Auditor, Quality Systems Specialist, Compliance Officer, Risk Management Specialist