Regulatory Affairs and Quality Manager

Responsibilities

Working in an English-speaking and fast-paced environment, you will lead the Regulatory Affairs, Quality System and Quality Assurance activities for the company.

You will have the opportunity to play a critical role in building the quality management and risk management processes of a dynamic start-up company and have a significant influence on the company’s compliance activities and regulatory strategy.

Primary responsibilities:

  • Initiate and lead interactions with the notified body and the competent authorities (FDA, BfArM, etc.)
  • Build out the company’s quality system from the existing R&D quality activities, in compliance with ISO 13485, 14971, cGMP and other applicable standards.
  • Prepare for and lead a certification audit of the quality system to support CE marking of the companies products
  • Develop, implement and maintain the company’s risk management processes
  • Develop and implement a QA staffing plan appropriate for evolution of the company’s R&D and manufacturing activities.
  • Build, implement and manage the quality assurance processes to support the internal manufacturing activities and supplier management responsibilities
  • Hire and manage the regulatory affairs and quality team

Qualifications

The candidate must have direct relevant experience working in a medical device environment:

  • Prior experience building and managing quality systems in the medical device environment.
  • Working knowledge and operational experience with applicable standards, including ISO 13485, ISO 14971, EN 45502 and MDD / AIMDD as well as 21 CFR part 820.
  • Prior experience managing quality assurance processes for production of medical devices.
  • Minimum working experience 5 years in a relevant position and at least 3 years of experience leading projects.
  • Bachelor’s or Master’s Degree in Engineering, Pharmacy, Chemistry or other related science discipline.
  • Written and oral fluency in English.

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.

Compensation and Logistics

• Starting date: ASAP
• Salary will be competitive and commensurate with experience and qualifications
• Contract: permanent contract (“CDI”), full-time
• Location : Clichy-Levallois
Please send your CV and letter of introduction to: careers@corwave.com, “RAQA Manager”