At a Glance
- Tasks: Join a startup to guide regulatory strategy and enhance quality systems in medical devices.
- Company: Rapidly growing MedTech startup focused on AI-enabled compliance solutions.
- Benefits: Competitive salary, equity participation, and fully remote work.
- Other info: Fast-paced environment with immediate start and excellent growth opportunities.
- Why this job: Make a real impact in healthcare by shaping regulatory technology from the ground up.
- Qualifications: Bachelor's degree and 2-6 years in Regulatory Affairs within medical devices required.
The predicted salary is between 36000 - 60000 £ per year.
Quality & Regulatory Affairs Specialist in Medical Device / IVD | AI-Enabled Compliance Platform Fully Remote (EU time zones) Immediate Start Required
About the Company
We are a rapidly growing, venture-backed MedTech startup developing AI-enabled solutions to modernise and simplify medical device and IVD compliance. Our technology-driven platform is designed to help innovative companies navigate global regulatory and quality requirements more efficiently, accelerating time to market for life-changing products. Founded by experienced industry leaders and technologists, we operate at the intersection of regulatory science, quality systems, and artificial intelligence in a highly collaborative, fast-paced startup environment.
The Opportunity
This is a rare opportunity to join a founding-stage medical device/IVD startup and play a critical, hands-on role in both product development and client success. Reporting directly to the Head of Quality & Regulatory Affairs, you will contribute across regulatory strategy, technical documentation, quality systems, client engagement, and AI-powered tooling. This role is fully remote, requires strong English communication skills, and is intended for candidates who can start immediately.
Key Responsibilities
- Provide expert regulatory, clinical, and quality guidance on technical documentation generated using internal compliance tools
- Prepare regulatory submission packages and respond to authority or Notified Body questions during evaluation periods
- Support client engagements from onboarding through development, submission, and post-market activities, under senior leadership guidance
- Collaborate closely with executive leadership and engineering teams to enhance quality systems, eQMS functionality, and AI-enabled regulatory tools
- Develop clear, user-friendly written and video guidance to support clients throughout their regulatory journey
- Contribute to the development, validation, and continuous improvement of new regulatory and quality solutions
- Support day-to-day quality and regulatory operations in a growing startup environment
- Monitor and interpret changes in global medical device and IVD regulations and emerging regulatory trends
- Optionally perform detailed reviews of client technical documentation
Required Qualifications
- Bachelor's degree in engineering, life sciences, or a related discipline
- 2–6 years of hands-on experience in Regulatory Affairs and/or Clinical Affairs within the medical device or IVD industry
- Direct experience working in a startup or early-stage medical device / IVD company (required)
- Hands-on experience authoring technical documentation (e.g., Clinical Evaluation Reports) for EU submissions
- Solid working knowledge of EU MDR (2017/745)
- Working knowledge of key standards and guidance, including: ISO 13485, ISO 14971, IEC 62304, MDCG, IMDRF, and FDA guidance documents
- Fluent written and spoken English (required)
- Strong communication skills and a customer-centric mindset
- Proven ability to work independently in a fast-paced, evolving startup environment
- Willingness to work flexible hours to support clients across multiple time zones
Bonus Experience
- Familiarity with US FDA medical device regulations (21 CFR)
- Experience with Software as a Medical Device (SaMD) and/or hardware medical devices
- Broader quality systems exposure (CAPA, PMS, vigilance, audits)
- Experience with Notified Body audits or conformity assessments
- Familiarity with FDA Q-Submissions, 510(k), PMA, and De Novo pathways
- Experience working with or prompt-engineering AI Large Language Models (LLMs)
What We Offer
- Competitive full-time salary
- Equity participation
- Fully remote work environment
- High-impact role with visibility across leadership, product, and clients
- Opportunity to shape the future of regulatory and quality technology from the ground up
Apply now for immediate consideration. This role is actively hiring with a fast interview and decision process.
Regulatory Specialist in Oxford employer: Maclivaro Limited
Join a dynamic and innovative MedTech startup that is revolutionising the regulatory landscape for medical devices and IVDs. As a fully remote employer, we offer a collaborative work culture that values your contributions and provides ample opportunities for professional growth in a fast-paced environment. With competitive salaries, equity participation, and the chance to work on cutting-edge AI-enabled solutions, this is an exceptional opportunity for those looking to make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in Oxford
✨Tip Number 1
Network like a pro! Reach out to people in the industry on LinkedIn or through professional groups. A friendly chat can sometimes lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and think about how your skills can help them tackle these issues. Show them you’re not just another candidate!
✨Tip Number 3
Practice your communication skills. Since this role requires strong English skills, try doing mock interviews with friends or using online platforms. Clear communication can set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Specialist in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Specialist role. Highlight your experience in regulatory affairs and any relevant technical documentation you've authored. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the MedTech industry and how your skills can contribute to our mission. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills:Since strong English communication skills are a must, make sure your application reflects this. Use clear and professional language, and don’t forget to proofread for any typos or errors. We appreciate attention to detail!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the quickest way for us to receive your application and get the ball rolling. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Regulations
Make sure you brush up on the EU MDR and other relevant regulations before your interview. Being able to discuss specific compliance requirements and how they relate to the role will show that you're not just familiar with the basics, but that you can navigate the complexities of regulatory affairs.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles, especially in startup environments. Highlight your hands-on experience with technical documentation and client engagement, as this will demonstrate your ability to contribute immediately to the team.
✨Communicate Clearly
Since strong communication skills are a must for this role, practice articulating your thoughts clearly and concisely. Consider preparing a brief presentation or summary of a past project to showcase your ability to convey complex information effectively.
✨Be Ready for Collaboration
This position involves working closely with various teams, so be prepared to discuss how you've successfully collaborated in the past. Think of examples where you enhanced quality systems or contributed to team projects, as this will highlight your collaborative mindset.
