Reporting to the Chief of RAQA & Clinical Global, you will be responsible for leading and shaping Wandercraft’s global RAQA strategy. Your mission will be to ensure regulatory excellence, quality system effectiveness, and compliance across all markets, while empowering and developing a high-performing RAQA team.

Main missions (non-exhaustive list)

Leadership and Team Management:

• Lead, mentor, and develop the RAQA team. Oversee hiring, training, and performance evaluation processes to ensure a high-performing and engaged team.

• Support the Chief of RAQA & Clinical Global by ensuring effective communication and collaboration within the team and across departments. Maintain strong relationships with internal and external stakeholders including regulatory bodies and industry partners.

• Manage the RAQA team’s budget, resources, and timelines in alignment with company objectives.

Regulatory Compliance:

• Ensure that medical devices are compliant with EU, US and other applicable global regulations.

• Maintain up-to-date company registrations and device lists.

• Oversee the planning, preparation, and submission of regulatory dossiers to secure market authorizations for new products and product iterations globally.

Quality Management System (QMS):

• Ensure the implementation, maintenance, and continuous improvement of the QMS.

• Oversee risk management activities in accordance with applicable standards.

• Lead and/or manage internal and external audits, ensuring timely resolution of findings.

Product Development:

• Contribute to product development strategies by integrating regulatory and quality considerations into decision-making.

• Develop and refine regulatory roadmaps to support innovation and market access.

• Ensure product development activities comply with applicable international standards and regulations.

Human Factors and Usability Engineering:

• Drive Human Factors studies and post-market surveillance activities, including data mining and documentation, in accordance with FDA and EU guidelines and standards.

• Ensure that ergonomic and user-centered design principles are integrated into product development and lifecycle management.

• Lead usability testing to enhance product safety, effectiveness, and user satisfaction.

Biocompatibility:

• Define biocompatibility strategy and direct related testing activities in compliance with applicable standards.

• Diploma: Advanced scientific degree (Master’s, Engineering, PharmD, or PhD).

• Required Experience: significant experience in Regulatory and Quality Affairs (ideally +5 years), with proven leadership/management experience preferred.

• Skills :

  • European Medical Devices Regulation (MDR)2017/745: expert

  • US Quality System regulation: 21 CFR Part 820: expert

  • ISO 14971 - Application of risk management to medical devices: expert

  • ISO 13485 Quality Management System

  • EN/IEC 62366-1: Usability: expert

  • ISO 10993 - Biocompatibility: autonomous

  • Fluent in English, with excellent communication skills (written and oral).

1. Screening

2. Interview with the Head of RAQA

3. Interview with a C-level

4. HR interview