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Head of Clinical & Regulatory Affairs

REEV

REEV

Legal
Posted on Thursday, July 4, 2024

About REEV:

At REEV, we are pioneering the development of DREEVEN: an intelligent robotic knee brace designed to help millions with neurological walking disorders regain confidence and freedom in their daily walking. As we prepare for clinical studies in the US to secure FDA approval and Medicare reimbursement, we are looking for a dynamic and driven professional to join our team. Our mission is to reinvent the personal mobility of millions with gait disabilities through innovative robotic technology and compassionate care.

Join us in making a significant impact in the medtech field and helping patients achieve greater independence.

Position:

As the Head of Clinical and Regulatory Affairs, you will ensure DREEVEN’s clinical and regulatory success. Your mission is to collaborate with business, product, and regulatory teams to optimize our clinical studies and ensure compliance with FDA and payer expectations. You will also be pivotal in synchronizing clinical, R&D, industrialization, and regulatory operations to adhere to our market roadmap.

Key Responsibilities:

  1. Study Optimization and Compliance:
    • Collaborate with business, product, and regulatory departments to refine the study definitions (protocol and cohort) of our US trials
    • Ensure all studies meet FDA and payer requirements, maintaining strict compliance throughout the process.
  2. Operational Synchronization:
    • Ensure seamless integration and synchronization of clinical, R&D, industrialization, and regulatory operations to align with our market roadmap.
    • Drive cross-functional collaboration to ensure timely and successful product development and market entry.
  3. Relationship Management:
    • Develop and maintain relationships with payers, understanding and aligning with their clinical expectations to facilitate a successful product launch.
    • Act as a liaison between the company and regulatory bodies, ensuring clear and effective communication.
  4. Regulatory Leadership:
    • Lead the FDA 510(k) Class II clearance process, ensuring all regulatory submissions are thorough and timely.
    • Oversee the ISO 60601 certification process for DREEVEN, ensuring compliance with international standards for medical electrical equipment.
    • Manage the ISO 13485 certification process for REEV, maintaining the highest standards for quality management systems in the medical device industry.

Skills

  • Expert knowledge of medical regulation, laws, procedures, and guidance for medical device development, ideally with robotics and AI components.
  • Demonstrated expertise in regulatory affairs science, including research and development, pre-clinical and clinical requirements.
  • Ability to lead the FDA 510(k) Class II clearance process and manage ISO 60601 and ISO 13485 certification processes.
  • Ability to assess regulatory pathways and strategies, providing recommendations based on regulatory outcomes.
  • Provides regulatory leadership on cross-functional teams.
  • Works effectively in a startup environment.
  • Ensures seamless integration of operations to align with the go-to-market roadmap.
  • Collaborates with various departments to refine study definitions and ensure compliance with FDA and payer requirements.
  • Develops and maintains relationships with payers, aligning with their clinical expectations.

Why Join REEV?

  • Innovative Environment: Be part of a cutting-edge medtech startup transforming neurological rehabilitation.
  • Impactful Work: Make a significant impact on the lives of people with walking disorders and their caregivers.
  • Collaborative Culture: Work with a passionate and dedicated team committed to making a difference.
  • Strong company values: Be driven by social impact, excellence, ambition, autonomy, and perseverance.
  • Professional Growth: Opportunities for professional development and career advancement as we grow and expand.
  • Competitive Compensation: Attractive salary and benefits package based on profile.

Contract:

This full-time position is based on-site in Toulouse, with travel activity to the US, specifically Boston, and includes the flexibility of one remote day per week. Remuneration based on experience. Proficiency in French and English is required.

We also feel that it’s important to point out the obvious here – there’s a serious lack of diversity in our industry, which needs to change. Our goal is to help drive that change. REEV is committed to diversity, equity, and inclusion in all its practices, especially in growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life. It is the policy of REEV to provide equal employment opportunities to all employees and employment applicants.