Medical Device Expert

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

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Job Description :

With a goal to continuously expand our international footprint, we are looking for a Medical Device Expert to join our team and support our growing Medical Device and In Vitro Diagnostic activities.

Responsibilities

As a Medical Device Expert, you will support Medical Device (MD) and In Vitro Diagnostic (IVD) manufacturers, from innovative start-ups to global industry leaders, in addressing their regulatory, quality and clinical challenges.

Your responsibilities will include:

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, including FDA 510(k) pathways where applicable
• Prepare, review and maintain technical documentation in accordance with Annex II and III of MDR/IVDR
• Support technical documentation and design compliance throughout the product lifecycle
• Prepare and review regulatory and technical documentation in English
• Interact with Notified Bodies and Health Authorities

Quality

• Support the implementation, maintenance and optimisation of Quality Management Systems
• Work with applicable standards and frameworks, including ISO 13485, ISO 9001 and MDSAP
• Support clients in preparing for internal and external quality audits
• Contribute to quality and regulatory compliance throughout the product lifecycle
• Identify compliance gaps and support the implementation of corrective actions

Clinical

• Lead and support clinical evaluation activities for Medical Devices
• Prepare and review Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)
• Support Post-Market Clinical Follow-up (PMCF) activities
• Ensure clinical documentation is aligned with applicable MDR/IVDR requirements
• Collaborate with regulatory, quality and clinical stakeholders

Education & Experience

• 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
• 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, including CEP, CER and/or PMCF
• Experience interacting with Notified Bodies and/or Health Authorities
• Previous consulting and client-facing experience is highly valued
• Experience managing projects and coordinating multiple stakeholders

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Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.

An international career, built around you

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster. Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one.

Why PLG is the place to work

• A path for every career stage, from graduate to senior expert
• Exciting, high-impact projects with leading life sciences clients
• International by design
• Hybrid & flexible working
• Continuous learning
• An inclusive & diverse culture