EU MDR Regulatory Affairs Specialist

3D Systems Corporation; Soesterberg; On-site; EUR 70,000 - 90,000; Full time

Job summary

Vertex-Dental, part of 3D Systems, is expanding its Regulatory Affairs team with an Intermediate Regulatory Affairs Officer to support EU MDR, Technical Documentation, labelling, and UDI activities. The role focuses on maintaining MDR Technical Documentation and ensuring regulatory compliance across product lifecycles.

You will collaborate with R&D, Quality, Manufacturing, and Clinical teams to drive timely regulatory submissions and market access, while monitoring regulatory changes to mitigate

Qualifications

• Minimum 3 years of Regulatory Affairs experience in medical device or dental device sectors.
• Experience with EU MDR 2017/745, labeling/IFU changes, and lifecycle maintenance.
• Ability to translate complex technical information into clear regulatory documentation.

Responsibilities

• Maintain MDR Technical Documentation and Technical Files throughout the product lifecycle.
• Coordinate technical documentation inputs from R&D, Quality, Manufacturing, Clinical, and other SMEs.
• Drive periodic review and improvement of MDR Technical Documentation and Technical Files.
• Perform impact assessments for product, process, labeling, and documentation changes.
• Support Notified Body audits, Technical Documentation reviews, and regulatory inspections.
• Maintain compliance of labeling, IFUs, declarations, and related regulatory documents.
• Oversee UDI and EUDAMED activities and regulatory registrations.

Skills

Analytical thinking

Attention to detail

Communication skills

Proactive mindset

Independent worker

Cross-functional collaboration

Organizational skills

Adaptability

Education

Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Chemistry, Materials Science, Regulatory Affairs, or related field

Job description

Vertex-Dental, part of 3D Systems, is expanding its Regulatory Affairs team with an Intermediate Regulatory Affairs Officer to support EU MDR, Technical Documentation, labelling, and UDI activities. The role focuses on maintaining MDR Technical Documentation and ensuring regulatory compliance across product lifecycles.

You will collaborate with R&D, Quality, Manufacturing, and Clinical teams to drive timely regulatory submissions and market access, while monitoring regulatory changes to mitigate