Drug/Device Combination Product, Risk Management Specialist

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Nivelles, Wallonie, Belgique Randstad Temps plein

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Location: Braine l'Alleud (Belgium) or Bulle( Switzerland) or 100% Remote (Europe)

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Employment Type: Consultancy/freelance contract -Full-time

Start date: ASAP

End date: March 2027 with possible extension.

About the Role

We are seeking a structured and detail-oriented Combination Products Risk Management Specialist . In this role, you will play a critical part in updating, harmonizing, and ensuring the compliance of technical documentation for autoinjectors and safety syringes across the product portfolio in preparation for an upcoming FDA inspection.

Operating within a fast-paced environment, you will bridge the gap between technical experts, Quality, Regulatory, and Safety teams to ensure all Risk Management Files (RMF) are robust, traceable, and fully aligned with internal and regulatory standards.

Key Responsibilities

Technical Risk Management Writing: Author, update, and maintain Risk Management Files (RMF)—including Risk Management Plans, FMEAs, Use-Related Risk Analyses, and Risk Management Reports—specifically for autoinjectors and safety syringes.
Traceability & Compliance: Conduct detailed gap analyses across legacy technical files (10–15 documents per file), design control records, and verification evidence to ensure full alignment with ISO 14971 principles.
Cross-Functional Coordination: Collaborate closely with Device Leads, Human Factors, Quality, and Regulatory stakeholders to collect, challenge, and consolidate technical data. Organize and lead review meetings to resolve documentation gaps.
Portfolio Harmonization: Upgrade older files across device families to ensure consistency across the product portfolio ahead of regulatory milestones.
Process Acceleration: Utilize internal AI tools (Copilot) and digital platforms to streamline data checking, review cycles, and documentation management.

Requirements

Education: Bachelor's or Master's degree in Engineering, Life Sciences, Technical Writing, or a related discipline.
Experience: 8–15 years of experience in medical devices, drug-device combination products, or regulated pharmaceutical environments.
Must-Have Expertise: Proven, hands-on experience with autoinjectors (mandatory) and in-depth expertise in ISO 14971 risk management standards.
Regulatory Frameworks: Solid understanding of EU MDR (Article 117), FDA 21 CFR Part 820/4, ISO 13485, and GMP requirements. xlxgzvr
Technical Skills: Advanced proficiency in Excel (for FMEA analysis) and familiarity with document management systems (e.g., Veeva Vault).
Languages: Professional fluency in English is mandatory

Drug/Device Combination Product, Risk Management Specialist

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