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- Tasks: Lead quality improvements and ensure regulatory compliance in medical diagnostics.
- Company: Genedrive is a pioneering medical device company focused on innovative diagnostic solutions.
- Benefits: Enjoy hybrid working, a supportive culture, and contribute to life-changing healthcare.
- Other info: This is a 12-month maternity cover role based in Manchester's innovation hub.
- Why this job: Join a passionate team making a global impact in healthcare with exciting growth opportunities.
- Qualifications: Degree in science/engineering and 3+ years in QA/RA within medical devices required.
The predicted salary is between 28000 - 36000 £ per year.
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.
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.
Quality Assurance & Regulatory Affairs Specialist employer: Genedrive
Contact Detail:
Genedrive Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with Genedrive's products and their impact on global healthcare. Understanding their mission and the specific technologies they develop will help you articulate how your experience aligns with their goals during any discussions.
✨Tip Number 2
Network with professionals in the QA/RA field, especially those who have experience in medical devices or IVDs. Engaging with industry groups or attending relevant webinars can provide insights and connections that may benefit your application.
✨Tip Number 3
Prepare to discuss your experience with ISO standards, particularly ISO 13485 and ISO 14971. Be ready to share specific examples of how you've implemented these standards in previous roles, as this will demonstrate your expertise and readiness for the position.
✨Tip Number 4
Showcase your ability to work collaboratively across departments. Think of examples where you've successfully partnered with other teams to achieve compliance or improve quality processes, as this is a key aspect of the role at Genedrive.
We think you need these skills to ace Quality Assurance & Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Quality Assurance & Regulatory Affairs Specialist position at Genedrive. Make sure you understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in QA/RA roles, particularly within the medical device or IVD sector. Use specific examples to demonstrate your understanding of ISO 13485 and your experience with audits and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also conveys your passion for improving patient outcomes through quality assurance. Mention how your skills align with Genedrive's mission and values.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in the QA/RA field.
How to prepare for a job interview at Genedrive
✨Understand the Regulatory Landscape
Familiarise yourself with the key regulations and standards relevant to the role, such as ISO 13485 and ISO 14971. Being able to discuss these frameworks confidently will demonstrate your expertise and commitment to compliance.
✨Showcase Your Analytical Skills
Prepare examples of how you've conducted root cause analyses or managed CAPA investigations in previous roles. Highlighting your analytical abilities will show that you can effectively tackle quality issues and drive improvements.
✨Emphasise Collaboration Experience
Since the role involves working with various departments and external stakeholders, be ready to share experiences where you've successfully collaborated on projects. This will illustrate your ability to work within cross-functional teams.
✨Prepare for Technical Questions
Expect questions related to QMS, audits, and regulatory submissions. Brush up on your technical knowledge and be prepared to discuss specific processes or challenges you've faced in your QA/RA career.