Regulatory Affairs Specialist

Your position as a Regulatory Affairs Specialist is in our Quality Management team where we always have various projects on the agenda. Regulatory affairs for medical devices is a wide area with a wide range of expertise in clinical and in technical aspects.

Your main responsibilities consists of:

• Collecting, registering, maintaining and distributing technical files for private label products in accordance with applicable laws and regulations.
• Collaborate with Product Management regarding regulatory strategy and new product development
• To review and update technical files for self-certification (i.e. class I medical devices) and certification in cooperation with a Notified body (i.e. class IIa medical devices).
• Monitoring external changes to the related standards and assess impact for Medeco B.V.
• Giving support and audit Medeco B.V. quality system based on internal and external requirements and developments.
• Support internal stakeholders with respect to the product/process requirements within the quality system
• Provide QA/RA guidance and information to all participants involved in law’s, regulations and (ISO) standards.
• Maintain contacts with (internal and external) clients and suppliers in relation to quality and regulatory aspects.

You are looking for the next step in your career and looking to work in a dynamic international team where you further build up your career in the regulatory environment. Next to that you are a talented professional with preferably toxicological experience.

Education & Experience

• Minimum a Bachelor’s level degree in the scientific or technical discipline
• Biomedical/pharmaceutical background or related education in life sciences (Medicine/Biology/Chemistry)
• Minimum of 2 years experience in regulatory affairs of medical devices and working with quality management standards

• Knowledge of medical device regulations and standards (MDR,  ISO 13485, ISO14971, ISO 10993, etc).
• Knowledge and experience with quality systems and their certification methods.
• Experience with or interested in technical file preparation and maintenance for products, processes and systems.
• Knowledge and experience to support the regulatory aspects related to medical devices during the product life-cycle, like vigilance, monitoring, complaints.