Quality Assurance & Regulatory Affairs Specialist
Posted 4 days ago by genedrive
£45,000 Per year
Undetermined
Hybrid
Manchester, England, United Kingdom
Summary: Join Genedrive as a Senior Quality Assurance & Regulatory Affairs Specialist, where you will play a pivotal role in ensuring compliance and driving improvements within the Quality Management System. This position is based in Manchester and is a full-time, 12-month maternity cover contract. You will collaborate with various departments and external stakeholders to maintain regulatory compliance and support product development processes. Your expertise will contribute to advancements in global medical diagnostics and patient outcomes.
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
Key Skills:
- 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
Salary (Rate): £45,000.00/year
City: Manchester
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 without sponsorship.
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!