Senior RAQA Manager

About the role:

As Senior RAQA Manager, you will be responsible for defining and implementing Waiv’s regulatory and quality strategy across our IVD software (SaMD) portfolio — RlapsRisk BC, BRCAura BC, MSIntuit Suite, and HistoPLUS/IHC. In a context of active CE-IVDR market access and emerging FDA regulatory pathway, you will operate with significant autonomy across the full regulatory and quality spectrum, working closely with Medical Affairs, R&D, and Project and Product teams.

Position is based in our Paris offices, with hybrid working available (at least two trips to the office per month).

Please submit your CV in English

In particular, you will:

• Regulatory Affairs

  • Define and implement regulatory strategies aligned with target markets (EU, US, and others) and business priorities

  • Identify, monitor, and assess the impact of new regulations, standards, and guidance documents (IVDR, MDR, FDA 21 CFR Part 820/830, MDCG guidances, IEC 62304/82304, ISO 14971)

  • Contribute to regulatory classification of new features or products (IUO vs. CE-IVD, SaMD classification, FDA De Novo / 510(k) strategy)

  • Support drafting and maintenance of regulatory documents: technical documentation (IVDR Annexes II/III), SEMD, declarations of conformity, change requests

  • Act as one of the primary contacts for communication with competent authorities (ANSM, FDA, Notified Body): inquiries, submissions, vigilance

  • Contribute to post-market surveillance and vigilance obligations: PMCF reports, PSUR/SSCP, trend analysis, incident reporting

  • Support regulatory design and oversight of pre-market and post-market performance studies, in collaboration with the Medical & Clinical Affairs team

  • Support the development team to ensure all regulatory requirements are met throughout the product lifecycle and post-commercialization activities, including participation in product risk analysis (ISO 14971)

  • Review and approve marketing and communication materials in compliance with product claims and applicable regulations

  • Act as deputy to the Person Responsible for Regulatory Compliance (PRRC), including: market release and device release for performance studies; ensuring conformity of technical documentation and declarations of conformity

    Quality Assurance

  • Participate in the implementation, maintenance, and continuous improvement of the QMS in accordance with applicable standards (ISO 13485, IVDR, FDA 21 CFR Part 820/830, IEC 62304/82304)

  • Contribute to drafting, reviewing, and updating QMS procedures, work instructions, and associated documents

  • Manage core quality processes: non-conformities, CAPAs, complaint analysis, deviations

  • Lead product risk management in collaboration with R&D and Medical Affairs teams (ISO 14971 — FMEA, risk matrix, benefit/risk assessment)

  • Approve change requests from a quality standpoint and ensure follow-up on implementation

  • Plan and conduct or support internal audits and Notified Body / competent authority audits

  • Review, approve, and authorize product release (including for performance studies) — as primary or deputy responsible

  • Act as the reference point for software tool qualification and associated quality infrastructure (CSV / Computer System Validation)

  • Manage qualification and oversight of critical suppliers and subcontractors (cloud, data, CRO, laboratories) in accordance with ISO 13485 §7.4

  • Collaborate with R&D, Data Science, and Medical Affairs teams to disseminate quality and regulatory best practices in a SaMD / AI context

  • Contribute to internal awareness and training on regulatory requirements applicable to medical software and AI in healthcare

  • Act as deputy to the Management Representative (ISO 13485 §5.5.2): ensure that QMS processes are documented, implemented, and maintained