Regulatory Affairs Specialist

Wat ga je doen?

Medeco BV is looking for a regulatory affairs team member. We are a medical device manufacturer in Europe with a wide portfolio of products to be used by healthcare professionals. Patients health and safety is our prime focus in the environment of the aging European population. We are actively supporting the growth of our business in the Mediq group, our mother company. For the essence of compliance in the legal frame work of the European medical device regulation and with all related authorities are we continuously monitoring and improving our documentation and proof of effectiveness.

Your position as a Regulatory Affairs Specialist is in our Quality Management team. You will help to ensure that our products are compliant with the regulatory requirements. The RA Specialist will report to the Regulatory Affairs Manager.

Your main responsibilities consists of:

• Collecting, registering, maintaining and distributing technical files for private label products in accordance with MDR 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
• 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 MDR regulation and (ISO) standards.
• Maintain contacts with (internal and external) clients and suppliers in relation to quality and regulatory aspects.

Wat vragen wij?

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 technical file experience.

Education & Experience & Skills

• Bachelor’s degree in a medical field, biomedical background or related education in life sciences.
• Minimum of 2 years’ experience in regulatory affairs of medical devices.
• Knowledge of Clinical Evaluation, Biocompatibility and risk management is a plus.
• Highly desirable – advanced knowledge of the new EU medical device regulation (MDR)
• Experience in own brand labeling of medical devices is preferred.
• Knowledge and experience to support the regulatory aspects related to medical devices during the product life-cycle, like vigilance reporting and complaints.
• Full professional proficiency in English.
• Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports. 

Wat bieden wij?

• Working at the heart of the organisation
  
• The possibility to grow in your career