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- Tasks: Manage quality and regulatory activities for innovative medical software technologies.
- Company: Join a cutting-edge digital health company making waves in medical technology.
- Benefits: Gain invaluable experience, competitive salary, and opportunities for professional growth.
- Why this job: Be at the forefront of healthcare innovation and make a real impact.
- Qualifications: Experience in QA or Regulatory Affairs within medical devices is essential.
- Other info: Dynamic startup environment with a culture of quality and continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with an innovative digital health company developing cutting-edge software-based medical technologies. As they prepare for upcoming FDA and EU MDR submissions, we have an exciting opportunity for a QA & Regulatory Affairs Specialist to join their growing team.
As the new QA & RA Specialist, you will take ownership of day-to-day quality and regulatory activities, supporting the development and maintenance of a Quality Management System for Software as a Medical Device (SaMD). Working closely with an experienced Regulatory Affairs Consultant, you will play a key role in documentation, audits, and submission preparation, gaining invaluable exposure across international regulatory frameworks.
Key Responsibilities
- Develop, implement, and maintain the Quality Management System (QMS) for SaMD in line with ISO 13485 and IEC 62304.
- Ensure compliance with ISO 14971, GDPR, HIPAA, and related privacy frameworks.
- Prepare and maintain key documentation including DHF, risk files, validation reports, and traceability matrices.
- Support FDA and EU MDR submissions, as well as internal audits and external inspections.
- Manage CAPA, post-market surveillance, and audit readiness.
- Collaborate cross-functionally with engineering and product teams to embed quality and compliance throughout development.
- Champion a culture of quality and continuous improvement across the organisation.
Experience and Skills Required
- Proven experience in QA and/or Regulatory Affairs within medical devices, ideally SaMD.
- Strong understanding of ISO 13485, IEC 62304, and ISO 14971.
- Experience working in fast-paced or startup environments.
- Excellent technical documentation, organisation, and communication skills.
- Proactive and adaptable, with strong problem-solving ability and attention to detail.
- Exposure to FDA 510(k), EU MDR Class II submissions, or audit participation advantageous.
- Familiarity with software validation or cybersecurity documentation desirable.
If you’re a motivated QA & RA professional looking to deepen your regulatory expertise in a fast-paced digital health environment, we’d love to hear from you.
QARA Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QARA Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the digital health space, especially those who work with QA and regulatory affairs. Attend industry events or webinars to make connections that could lead to job opportunities.
✨Tip Number 2
Show off your skills! Prepare a portfolio or a presentation that highlights your experience with ISO standards and regulatory submissions. This can really set you apart during interviews and give you a chance to demonstrate your expertise.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers, especially around compliance and quality management systems. The more comfortable you are discussing your experience, the better you'll perform.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for passionate QA & RA professionals. Keep an eye on our listings and make sure your application stands out by tailoring it to the specific role.
We think you need these skills to ace QARA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QARA Specialist role. Highlight your experience with ISO standards and any relevant regulatory submissions. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality and regulatory affairs in the digital health space. Let us know how you can contribute to our mission.
Showcase Your Experience: When detailing your experience, focus on specific projects or roles where you've managed quality systems or regulatory submissions. We love seeing concrete examples of your work and how it relates to SaMD.
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 your enthusiasm for joining our team!
How to prepare for a job interview at Cure Talent
✨Know Your Standards
Familiarise yourself with ISO 13485, IEC 62304, and ISO 14971 before the interview. Being able to discuss these standards confidently will show that you understand the regulatory landscape and can contribute effectively to the Quality Management System.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed QA or regulatory affairs in medical devices. Highlight any experience with FDA submissions or audits, as this will resonate well with the interviewers looking for someone who can hit the ground running.
✨Emphasise Collaboration
Since the role involves working closely with engineering and product teams, be ready to discuss how you've collaborated cross-functionally in previous positions. Share instances where your input helped improve quality or compliance, showcasing your ability to champion a culture of quality.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality and regulatory challenges, especially in the context of software as a medical device. This not only shows your interest in the role but also your proactive mindset towards continuous improvement.