Senior RAQA Manager

Role Overview

Join Waiv as a Senior RAQA Manager to define and implement the regulatory and quality strategy for our IVD software portfolio. You will work closely with various teams and operate with significant autonomy across the full regulatory and quality spectrum.

Key Responsibilities

• Define and implement regulatory strategies aligned with target markets and business priorities
• Contribute to the drafting and maintenance of regulatory documentation, including technical documentation
• Implement, maintain, and continuously improve the quality management system
• Draft and defend complex technical dossiers and regulatory arguments
• Interact with Notified Bodies, FDA, and international regulatory partners

Required Qualifications

• Master's degree (Bac+5) in pharmacy, biomedical engineering, life sciences, or equivalent
• 6 to 10 years of experience in RAQA in the medical device sector, with strong IVD exposure
• Demonstrated experience on at least one completed CE-IVDR/IVD dossier (initial marking, maintenance, or renewal)
• Mandatory experience with medical software (SaMD, IEC 62304)
• Strong command of IVDR, ISO 13485, ISO 14971, IEC 62304/82304
• Knowledge of FDA SaMD requirements (AI/ML guidance 2021, PCCP, De Novo/510(k))
• Fluency in English with ability to communicate with regulatory bodies and international partners

Nice-to-Have Qualifications

• Experience in AI/ML applied to healthcare
• Familiarity with HTA/reimbursement processes (RIHN, HAS)
• Experience in a scale-up or startup environment
• French language skills