Medical Device Expert (MDR/IVDR Regulatory & Quality)

About the role

ProductLife Group is expanding its international footprint and is looking for a Medical Device Expert to support its growing Medical Device and In Vitro Diagnostic activities. You will help manufacturers, from start-ups to global leaders, solve their regulatory, quality and clinical challenges.

Key responsibilities

• Regulatory affairs: develop and implement regulatory strategies for medical devices and IVDs; support compliance with EU MDR 2017/745 and EU IVDR 2017/746; contribute to international regulatory activities such as FDA 510(k) pathways where applicable
• Prepare, review and maintain technical documentation in line with Annex II and III of MDR/IVDR, in English, and support design compliance throughout the product lifecycle
• Interact with Notified Bodies and Health Authorities
• Quality: support Quality Management Systems, work with ISO 13485, ISO 9001 and MDSAP, prepare clients for audits, identify compliance gaps and support corrective actions
• Clinical: lead clinical evaluation, prepare and review Clinical Evaluation Plans and Reports, support Post-Market Clinical Follow-up and ensure clinical documentation meets MDR/IVDR requirements
• Collaborate with regulatory, quality and clinical stakeholders

Required profile

• University degree in Pharmacy, Life Sciences, Biomedical Sciences, Engineering or another relevant scientific discipline
• 5+ years of professional experience in medical devices and/or IVDs
• Previous consulting and client-facing experience is highly valued
• Experience managing projects and coordinating multiple stakeholders

Required skills

• Strong knowledge of EU MDR and/or IVDR
• Hands-on experience preparing and reviewing technical documentation
• Strong knowledge of ISO 13485 and Quality Management Systems
• Experience in clinical evaluation (CEP, CER, PMCF)
• Experience interacting with Notified Bodies and/or Health Authorities