Quality & Regulatory Affairs Specialist
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.
