Boudicca DX™
We are a precision medicine product development accelerator powered by an expert team of accessible, knowledgeable, and reliable On Demand consultants. We help clients deliver first‑in‑class and best‑in‑class precision medicine products to patients by increasing their probability of commercial, regulatory, and technical success. With decades of experience and unparalleled knowledge, we partner with clients at all stages of development to provide specialized and focused consulting services. Our clients include academic institutions, biotech companies, clinical laboratories, and more.
Medical Regulatory Consultant
We are seeking an experienced Medical Regulatory Consultant to join our global team of precision medicine experts. This individual will contribute to the development and delivery of global regulatory and quality compliance strategies for our clients, ensuring compliance with the EU MDR (2017/745), IVDR (2017/746), and other relevant frameworks.
The ideal candidate will combine technical regulatory expertise with strong strategic insight, supporting product development from concept through commercialization—including study design, CE‑marking, and market access.
Qualifications
* • Bachelor’s or Master’s degree in a scientific, engineering, or regulatory discipline (or equivalent)
* • Minimum 5 years of regulatory affairs experience in the medical device, IVD, or digital health sector
* • Demonstrated understanding of EU MDR and IVDR, including conformity assessment, performance evaluation, and CE‑marking requirements
* • Proven experience preparing regulatory submissions and managing interactions with notified bodies or competent authorities
* • Solid understanding of clinical evidence requirements for IVDs, SaMD, or combination products
* • Ability to interpret and apply relevant ISO and IEC standards (e.g., ISO 13485, ISO 14971, IEC 62304)
* • Excellent written and verbal communication skills in English
* • Strong analytical, organizational, and project management abilities
Job Details
* Seniority level: Mid‑Senior level
* Employment type: Contract
* Job function: Legal
* Industries: Business Consulting and Services
Location: Limerick, County Limerick, Ireland
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