ProductLife Group

Medical Device Expert (MD & IVD) – Regulatory, Quality & Clinical

Casablanca

CDI / Temps pleinHybride5–10 ansLicence / Bac+3AnglaisQualité / HSESanté

L’essentiel du poste

Résumé par Postule AI

ProductLife Group is hiring a Medical Device Expert to support medical device (MD) and in vitro diagnostic (IVD) manufacturers, from start-ups to global leaders, with regulatory, quality and clinical challenges. The role covers EU MDR/IVDR compliance, technical documentation, ISO 13485 quality systems and clinical evaluation. It is a full-time, mixed work-mode position based in Casablanca, Morocco, requiring 5+ years of experience in medical devices and/or IVDs.

Vos missions

  • Develop and implement regulatory strategies for medical devices and IVDs, including EU MDR/IVDR compliance and FDA 510(k) pathways where applicable.
  • Prepare, review and maintain technical documentation under MDR/IVDR Annex II and III, and interact with Notified Bodies and Health Authorities.
  • Support Quality Management Systems (ISO 13485, ISO 9001, MDSAP), quality audit preparation and implementation of corrective actions.
  • Lead and support clinical evaluation activities, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and PMCF activities.
  • Collaborate with regulatory, quality and clinical stakeholders while supporting clients from innovative start-ups to global industry leaders.

Profil recherché

  • You have 5+ years of experience in medical devices and/or IVDs, with EU MDR/IVDR or ISO 13485 work
  • You enjoy hands-on technical documentation and clinical evaluation work
  • You are comfortable working with Notified Bodies, Health Authorities and client stakeholders
  • You have consulting or client-facing experience and manage projects across multiple stakeholders

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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.

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.

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.

Responsibilities

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

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.

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