Regulatory Affairs Specialist Medical Devices
il y a 4 jours
As a key member of the European Healthcare Regulatory Affairs team at Capijobnew, you will play a crucial role in ensuring full compliance with the European Medical Device Vigilance Process for our Medical Device product portfolio. Your primary responsibility will be to lead the communication with affected competent authorities and notified bodies, particularly with the ANSM.
You will serve as the Business partner for quality, acting as the interface between regulatory and quality to ensure that regulatory requirements are properly captured in our Quality Management System (QMS) and various procedures. You will define processes with clear roles and responsibilities across functions.
You will provide regulatory support to Medical Device Teams in case of vigilance situations and act as the Person Responsible for Regulatory Compliance (PRRC) for Laboratoires Anios, as per Article 15 of REGULATION (EU) 2017/745.
You will liaise with notified bodies and competent authorities in your area of responsibility, providing subject matter expertise in compliance audits and inspections. You will contribute to risk assessments and maintain and share your knowledge.
Requirements:
- Master's degree in chemistry, biology, toxicology, quality, engineering, or any other related field.
- 3 to 5 years of work experience in regulatory affairs or quality management systems related to Medical Devices.
- Experience in dealing with regulatory Agencies/Notified Bodies (ANSM).
- Ability to develop skills in other regulatory areas, such as biocides, cosmetics, and human drugs.
- First-hand 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.
- You are rigorous, reactive, proactive, autonomous, flexible, and organized.
Location: The position is preferably based in Lezennes (59). You will be required to travel across Europe and possibly other regions. Part of the interview will be conducted in English.
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