Chargà d'affaires RÃglementaires Dispositifs MÃdicaux (H/F)

Responsibilities

As a member of the European Healthcare Regulatory Affairs team, you will:

• Ensure full compliance with the European Medical Device Vigilance Process for the Ecolab/Anios Medical Device product portfolio and lead communication to the affected competent authorities and notified bodies, in particular with the ANSM.
• Act as the Business Partner for quality, serving as the interface between regulatory and quality to ensure that regulatory requirements are properly captured in the QMS and in related procedures and processes, defining roles and responsibilities across functions.
• Provide regulatory support for Medical Device Teams in vigilance situations.
• Act as PRRC – Person responsible for Regulatory Compliance – for Laboratoires Anios, according to Article 15 of Regulation (EU) 2017/745.
• Liaise with notified bodies and competent authorities in your area of responsibility.
• Provide subject matter expertise in compliance audits and inspections.
• Contribute to risk assessments.
• Maintain and share knowledge.

Qualifications, Experience, Knowledge & Competencies

• Master's degree in chemistry, biology, toxicology, quality, engineering or a related field.
• 3 to 5 years of work experience in regulatory affairs or quality management systems related to medical devices.
• Experience dealing with regulatory agencies and notified bodies (ANSM). If not already experienced, ability to develop skills in other regulatory areas such as biocides, cosmetics and human drugs.
• First proven experience in leadership, project management, problem solving and team development skills.
• Ability to respond quickly in emergency situations related to product registration and public health issues (vigilance activities).
• Strong communication skills at an executive level.
• Demonstrated ability to influence across a matrix environment with multiple stakeholders and competing priorities, in an international environment.
• Fluent in French and English, with good written and verbal communication skills.
• Rigorous, reactive, proactive, autonomous, flexible and organized.

The position is preferably based in Lezennes (59). Agree to travel across Europe and possibly other regions.