Medical Device Specialist at ProductLife… · Tunis

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 :

We are looking for a Medical Device Specialist to join our team and support Quality Assurance and Regulatory Affairs activities for medical devices and in vitro diagnostic products.

Remote | 12-month contract.

The position may involve occasional travel to Belgium, Italy, and Turkey.

Responsibilities

Quality Assurance (QA)

• Support and maintain the Quality Management System (QMS)
• Review, update, and manage Standard Operating Procedures (SOPs)
• Participate in internal audits and support external audits conducted by Notified Bodies
• Manage CAPAs, change controls, and complaint handling activities
• Support batch release activities through documentary compliance reviews
• Conduct supplier evaluations and support supplier qualification and audit activities
• Ensure compliance with applicable quality standards and regulatory requirements

Regulatory Affairs (RA)

• Support CE marking activities for medical devices and IVDs
• Prepare, update, and maintain Technical Documentation/Technical Files
• Develop and maintain GSPR checklists
• Support Risk Management activities, including plans, analyses, and reports
• Contribute to Clinical Evaluation documentation (CEP, CER)
• Support Post-Market Surveillance activities, including PMS Plans, PSURs, PMCF Plans, and Reports
• Respond to regulatory requests from EU and international distributors
• Support product registrations and regulatory submissions in non-EU markets

Experience & Qualifications

• Scientific degree (Life Sciences, Biomedical Engineering, Pharmacy, or related field)
• Minimum 3 years of experience in Medical Devices and/or IVDs
• Experience in both Quality Assurance and Regulatory Affairs activities
• Good knowledge of EU MDR and/or IVDR requirements
• Experience with technical documentation and Quality Management Systems
• Fluency in English and French
• Strong writing, communication, and problem-solving skills
• Ability to manage multiple priorities and work in an international environment

Nice to Have

• Previous experience supporting Notified Body audits
• Supplier auditing experience
• Knowledge of international regulatory frameworks outside the EU

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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.