Your new role
As a Regulatory Affairs Specialist you will be part of your new employer’s Quality Management team. Next to you there are 2 more colleagues (Head of and and a Teamlead RA). In this role you will cover a wide area with a wide range of expertise in clinical and in technical aspects.
Your tasks include:

• Collecting, registering, maintaining and distributing technical files for private label products in accordance with applicable laws and regulations.
• Collaborating with Product Management regarding regulatory strategy and new product development
• Reviewing and updating 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 assessing impact for Medeco B.V.
• Giving support and audit the quality system based on internal and external requirements and developments.
• Supporting internal stakeholders with respect to the product/process requirements within the quality system
• Providing QA/RA guidance and information to all participants involved in laws, regulations and (ISO) standards.
• Maintaining contacts with (internal and external) clients and suppliers in relation to quality and regulatory aspects.

Your profile
In order to be successful as a Regulatory Affairs Specialist you have at least a Bachelor’s degree in the Biomedical/pharmaceutical field or a related education in life sciences (Medicine/Biology/Chemistry). You combine this educational background with at least 2 years of experience in regulatory affairs of medical devices and working with quality management standards. You have knowledge of medical device regulations and standards (MDR, ISO 13485, ISO14971, ISO 10993, etc). Next to this, you also have knowledge and experience with quality systems and their certification methods. Ideally, you also have experience with or you are interested in technical file preparation and maintenance for products, processes and systems. Finally, you know how to support the regulatory aspects related to medical devices during the product life-cycle, like vigilance, monitoring, complaints.

About the organization
You will be working for a leading player in healthcare. They have 2600 colleagues in 13 countries and their vision is to improve the outcomes and affordability of care. Their teams have consistently delivered throughout the pandemic with their employee engagement at an ultimate high. THey have kept their supply chain stable and their people safe, ensuring the healthcare system and patients across Europe are cared for.
You will be based in the HQ in Utrecht, together with 500 colleagues.

The benefits
Next to your salary, you will receive good secondary benefits and there is plenty of opportunity to grow and develop your skills. The team works with a hybrid model, partially in Utrecht, partially from home.

What you need to do now
Are you interested in this vacancy as Regulatory Affairs Specialist? Click 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1045999