Regulatory Affairs Specialist Medical Devices – Lisbon Based

The CHRISTEYNS Group provides the many customers who place their trust in it with effective and innovative cleaning and disinfection solutions in the linen, food processing, professional hygiene and life sciences sectors. Its presence in more than 30 countries with a turnover of 350 million euros and more than 1000 employees makes it a major player on the French and international markets.

Christeyns France, the French subsidiary of the Christeyns group, manufactures a wide range of chemical products, in particular cleaning and disinfection products for professional hygiene, industrial laundries, the food, cosmetics and pharmaceutical industries, as well as medical devices and disinfectants for the medical sector. The company currently employs 170 people in France and has a turnover of more than 60 million euros with a strong ambition for growth.

To strengthen a Scientific & Regulatory Affairs Department of Christeyns France, we are looking for a full-time m/f

 

Mission:

  • Preparation, updating and submission of technical dossiers, commercial and regulatory documents of medical devices.
  • Lead risk management, usability and post-market surveillance activities, including protocol and reporting, as well as coordination with relevant departments.
  • Management of materiovigilance, including assessment of materiovigilance events.
  • Contact the relevant authorities when necessary.
  • Ensure compliance with regulations relating to medical devices and conduct a competitive watch on medical devices.
  • Collaboration in a multi disciplinary team with Regulatory, Quality, Technical, Marketing, R&D and Production in order to assure compliance with the Medical Devices Regulation.
  • Participate in internal and external audits related to Medical Devices, prepare these audits in advance, and follow up on improvement actions.

 

The candidate:

  • Master’s degree in a scientific field (pharmaceutical, chemistry).
  • Preferably, applicants should have a few years of experience in regulatory affairs in the chemical, biochemical or pharmaceutical sector.
  • Knowledge of the requirements of ISO 13485, Regulation (EU) 2017/745, and Directive 93/42/EEC and its amendments.
  • Knowledge of usability, clinical evaluation, risk management, product design, management of non-conformities and preventive / corrective actions.
  • Proficiency in English (read, written, spoken) and French (read, written, spoken).