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- Tasks: Lead the Quality Management System and drive regulatory strategy for innovative IVD products.
- Company: Join TACHMED, a cutting-edge digital health company transforming diagnostics.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Shape a vital function in a fast-paced environment and make a real impact.
- Qualifications: 5+ years in Quality/Regulatory Affairs with strong knowledge of FDA and ISO standards.
- Other info: Be part of a dynamic team with high visibility and ownership at the executive level.
The predicted salary is between 36000 - 60000 £ per year.
TACHMED is an innovative digital health company developing connected in vitro diagnostic (IVD) systems comprising biochemical assays, hardware instrumentation, and regulated software and algorithms. R&D and validation is performed in-house in our London labs, with outsourced commercial manufacturing. The company is currently progressing its flagship products toward regulatory submission and commercialisation. This is a hands‑on, senior role with responsibility for building, operating, and scaling a compliant Quality and Regulatory function in a fast‑growing, highly technical environment.
We are seeking an experienced Quality Assurance & Regulatory Manager to lead the implementation and operation of our Quality Management System (QMS) and to drive regulatory strategy and submissions for our IVD products. The role reports directly to the General Counsel and acts as Quality Management Representative (QMR). The QA/RA Manager role is hybrid.
Key Responsibilities- Quality Management
- Plan, implement, and manage the TACHMED Quality Management System (ISO 13485)
- Act as Quality Management Representative (QMR) with authority to establish, maintain, and report on QMS performance to Executive Management
- Chair and lead required periodic Management Review meetings
- Ensure all employees, contractors, and suppliers operate in compliance with QMS procedures
- Train internal teams on quality and regulatory processes
- Monitor QMS performance and implement continuous improvements
- Establish and maintain risk‑based quality processes appropriate to the company’s development stage
- Support the transition from manual to electronic QMS (eQMS)
- Maintain quality oversight of external manufacturers, CROs, and suppliers through audits, quality agreements, and performance monitoring.
- Regulatory Affairs
- Coordinate FDA submissions in collaboration with internal teams and external regulatory CROs
- Develop regulatory pathways for IVD products, including: Predicate selection, Intended use definition, Analytical, clinical, and performance evaluation strategies
- Support interactions with notified bodies and regulatory authorities
- Prepare, review, and submit regulatory documentation (e.g. FDA 510(k), CE Mark, EU IVDR)
- Ensure compliance with applicable regulations (FDA, EU IVDR, ISO 13485, regional requirements)
- Apply appropriate quality and regulatory controls to software and algorithm development, including lifecycle management and validation
- Monitor regulatory changes and provide regulatory intelligence to the business
- Support internal and external audits and ensure inspection readiness
- Manage regulatory registers, submissions, and annual fees
- Maintain accurate, controlled regulatory documentation.
- ISO 13485 Lead Auditor qualification or equivalent audit leadership experience
- 5+ years’ experience in Quality and/or Regulatory Affairs within IVD or medical devices
- Proven experience with regulatory submissions and approvals
- Strong knowledge of FDA, EU IVDR, ISO 13485
- Experience with ISO 14971 risk management
- Familiarity with software‑based diagnostics and IEC 62304
- Experience working with outsourced development and manufacturing models
- Background in a start‑up or fast‑paced environment preferred
- Excellent communication, organisation, and stakeholder management skills.
- Proactive, self‑directed working style
- Strong attention to detail
- Ability to manage multiple priorities
- Confident influencer across technical and non‑technical teams
- Experience with Microsoft 365, Excel, and eQMS platforms.
- Build and shape a Quality & Regulatory function from the ground up
- Work at the intersection of assays, hardware, software, and algorithms
- High ownership, real impact, and visibility at executive level
- Opportunity to grow with the company as products move to market.
QA/RA Manager employer: TACHMED
Contact Detail:
TACHMED Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching TACHMED and understanding their products and values. Tailor your responses to show how your experience aligns with their mission and the specific requirements of the QA/RA Manager role.
✨Tip Number 3
Practice common interview questions and scenarios related to quality management and regulatory affairs. This will help you articulate your expertise confidently and demonstrate your problem-solving skills in real-time.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows your genuine interest in joining TACHMED and being part of their innovative journey.
We think you need these skills to ace QA/RA Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA/RA Manager role. Highlight your experience with ISO 13485 and regulatory submissions, as these are key for us. Use specific examples that showcase your skills in quality management and regulatory affairs.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Explain why you're passionate about digital health and how your background fits with TACHMED's mission. Don’t forget to mention your hands-on experience and how you can contribute to building our Quality Management System.
Showcase Your Achievements: When filling out your application, be sure to include quantifiable achievements. Whether it’s successful regulatory submissions or improvements in QMS performance, we want to see how you've made an impact in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at TACHMED!
How to prepare for a job interview at TACHMED
✨Know Your QMS Inside Out
Make sure you’re well-versed in ISO 13485 and the specifics of TACHMED's Quality Management System. Be ready to discuss how you would implement and manage a QMS, as well as any past experiences that demonstrate your expertise in this area.
✨Showcase Your Regulatory Savvy
Prepare to talk about your experience with regulatory submissions, especially FDA 510(k) and CE Mark processes. Highlight any successful strategies you've used in the past to navigate complex regulatory environments, as this will show you can handle the demands of the role.
✨Demonstrate Your Leadership Skills
As a QA/RA Manager, you’ll need to lead teams and influence stakeholders. Think of examples where you’ve successfully trained teams or led management review meetings. This will help illustrate your ability to drive compliance and quality culture within the organisation.
✨Be Ready for Technical Questions
Brush up on your knowledge of risk management (ISO 14971) and software-based diagnostics (IEC 62304). Expect technical questions that assess your understanding of these areas, as they are crucial for the role. Showing confidence in these topics will set you apart from other candidates.