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Head of Regulatory and Quality Affairs (RAQA)

Wandercraft is hiring!

About

The company:

Wandercraft provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to color, religion, sex, sexual orientation, gender identity, national origin, age or disability.

At Wandercraft we pioneer intelligent robotics to help people do what they can’t do. We apply the most advanced robotics and AI to expand what’s possible for humans in the fields of healthcare and now industry. Founded in 2012, Wandercraft is globally recognized for creating the world’s first self-balancing walking exoskeleton, Atalante X, which is used in more than 100 rehabilitation centers across four continents helping individuals with disabilities re-learn how to walk, with over a million steps taken each month.

Building on over a decade of real-world experience and a proprietary neural network trained on billions of steps, we’re bringing mobility beyond clinical settings and into the home. Our personal exoskeleton, Eve, is a first-of-itskind device designed to assist wheelchair users in standing and walking in everyday life. Now we’re expanding our platform to support industrial and assistive tasks with the Calvin family of humanoid robots. Built in just 40 days, Calvin-40 is designed to relieve factory workers from hazardous labor. Future versions of Calvin will assist persons with reduced autonomy in their daily activities.

Our growth into home and industrial robotics opens new horizons while reinforcing our ability to scale innovation, improve reliability, and accelerate our impact, across our entire portfolio of products and industries. From Paris and New York, our team of over 110 engineers, clinicians, researchers, and operators is united by one mission: to design robotics that improve human life, wherever people need them most!

We’re not just hiring people: we’re building a team of pioneers, curious minds and problem solvers who want to change the world, step by step.

Join us to shape the next generation of medical and humanoid robotics powered by AI and purpose.

Job Description

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.

Preferred Experience

  • 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).

Recruitment Process

  1. Screening

  2. Interview with the Head of RAQA

  3. Interview with a C-level

  4. HR interview

Additional Information

  • Contract Type: Full-Time
  • Start Date: 01 October 2025
  • Location: Paris
  • Education Level: Master's Degree
  • Experience: > 5 years
  • Possible partial remote
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