Medical Device Specialist

Il y a 1 semaine

Tunisie ProductLife Group Télétravail Temps plein

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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

Amériques

Europe

Asie / Océanie

Afrique

Medical Device Specialist

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