Senior RAQA Manager

Role overview

Senior RAQA Manager at Waiv. You will define and implement the regulatory and quality strategy for the company’s IVD software portfolio, working with multiple teams with significant autonomy across the regulatory and quality lifecycle.

Key missions

• Define and implement regulatory strategies aligned with target markets and commercial priorities.
• Contribute to the drafting and maintenance of regulatory documentation, including technical documentation.
• Support implementation, maintenance, and continuous improvement of the Quality Management System (QMS).

Requirements

• Master’s degree (Bac+5) in pharmacy, biomedical engineering, life sciences, or equivalent.
• 6–10 years of RAQA experience 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), including IEC 62304.
• Strong knowledge of IVDR, ISO 13485, ISO 14971, and IEC 62304/82304.
• Knowledge of FDA SaMD requirements (incl. AI/ML guidance 2021, PCCP, De Novo / 510(k)).
• Ability to draft and defend complex technical and regulatory dossiers.
• Fluent English for regular interactions with Notified Bodies, FDA, and international partners.

Nice to have

• Familiarity with HTA/reimbursement processes (RIHN, HAS).
• Experience in a scale-up/startup environment.
• French language skills.

Location / work mode

Full remote with base in Paris, France, with hybrid working available.