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 Specialist
Manchester, 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

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