Regulatory Affairs Manager

The Role

Holistick Medical is seeking a

Regulatory Affairs Manager (female/male)

You will lead the Regulatory Affairs, Quality System and Quality Assurance activities for the company. You will have the opportunity to develop the regulatory strategy of the company and to play a critical role in building the quality management system of a dynamic start-up company. Your contributions will significantly influence the company’s compliance activities and further direction.

This is a full-time opportunity based in Paris, France and reports directly to the CEO.

Key responsibilities will include:

  • Develop the company’s global regulatory strategy
  • Initiate and lead interactions with the notified body and the competent authorities (FDA, BfArM, etc.)
  • Build out the company’s quality management system from the existing R&D and quality activities, in compliance with ISO 13485, ISO 14971, cGMP and other applicable standards
  • Supporting the submission dossiers for the initiation of clinical studies
  • Build, implement and manage the quality assurance processes to support the internal manufacturing activities and supplier management responsibilities
  • Develop, implement and maintain the company’s risk management processes
  • Develop and implement an RA and QA staffing plan appropriate for the evolution of the company’s activities, including the identification of external advisors and consultants
  • Prepare for and lead a certification audit of the quality system

Candidate Profile

The successful candidate will be highly motivated, hard-working, autonomous, team oriented, and driven by a positive attitude. Flexibility to work in a start-up environment, requiring lean, efficient use of resources are required for success in this position.

Desired Skills:

  • Direct relevant experience working in a medical device environment, specifically class-III implants
  • Prior experience building and managing quality systems in the medical device environment
  • Knowledge and operational experience with applicable standards, including ISO 13485, ISO 14971, and MDD as well as 21 CFR part 820
  • Understanding processes and identify critical gaps and areas for improvement
  • Ability to communicate, train and provide guidance
  • Familiarity with standard project management tools and design controls
  • Excellent communication skills

Desired Qualifications:

  • Bachelor’s or Master’s Degree in Engineering, Pharmacy, Chemistry or other related science discipline
  • Minimum of 5 years’ experience in medical device or pharmaceutical industry, minimum 3 years in leading projects
  • Fluent command of English, French is a nice-to-have

Personal Characteristics

  • Ethics and personal values: The candidate is expected to operate with the highest levels of ethics and values and function in full trust from the team, the board and the investors
  • Ownership and drive to execution: Hands-on, down-to-earth, self-driven and able to work with minimum day-to-day supervision
  • Hands-on attitude, out of the box thinking, cooperative attitude
  • Strong sense of urgency and problem-solving skills, stress-resistance
  • Strong attention to detail, organizational and time management skills
  • Ability to see “the big picture” within the project in order to be a primary resource to others