REGULATORY AFFAIRS OFFICER
ABOUT VERTEX-DENTAL
Vertex-Dental, part of 3D Systems, is a leading manufacturer of advanced dental and medical device materials, serving customers worldwide. As part of our continued commitment to regulatory excellence and global market access, we are expanding our Regulatory Affairs team with one Intermediate Regulatory Affairs Officer. The position provides a unique opportunity to contribute to MDR compliance, technical documentation excellence, and global market access activities.
JOB OVERVIEW
We are seeking a Regulatory Affairs professional with a strong interest and experience in EU MDR, Technical Documentation and labelling to support and strengthen the regulatory team.
The primary focus of this position is the ongoing maintenance and regulatory compliance of MDR Technical Documentation, labelling, UDI, and related regulatory records. The role also supports international registrations and market access activities where technical documentation serves as the foundation for regulatory submissions.
RESPONSABILITIES
Regulatory Documentation & Compliance
- Independently prepare, remediate, review, and maintain MDR Technical Documentation in accordance with EU MDR 2017/745 throughout the product lifecycle
- Coordinate technical documentation inputs from R&D, Quality, Manufacturing, Clinical, and other subject matter experts.
- Drive the periodic review, maintenance, and continuous improvement of MDR Technical Documentation and Technical Files throughout the product lifecycle.
- Perform impact assessments for product, process, labelling, and documentation changes.
- Support Notified Body audits, Technical Documentation reviews, and regulatory inspections.
- Maintain compliance of labelling, Instructions for Use (IFU), declarations, and associated regulatory documentation.
Labelling & Regulatory Information Management
- Review and maintain product labelling and IFUs to ensure compliance with EU MDR and applicable international requirements.
- Assess the regulatory impact of labelling changes and coordinate implementation activities.
- Support label content reviews, translations, artwork approvals, and change control activities.
- Ensure consistency between Technical Documentation, product labelling, UDI records, and regulatory registrations.
UDI & EUDAMED Activities
- Support UDI assignment, EUDAMED registrations, device registration activities, and lifecycle maintenance of regulatory databases.
- Assess the impact of product, labeling, and documentation changes on regulatory compliance and database maintenance activities.
Regulatory Compliance & Intelligence
- Monitor regulatory developments and analyse potential impacts on company products and business operations.
- Identify regulatory risks and recommend appropriate mitigation strategies.
- Support business functions by providing practical regulatory guidance and advice.
Cross-Functional Collaboration
- Independently drive regulatory projects and coordinate activities across multiple functions to ensure timely delivery of regulatory, compliance, and market access objectives.
- Facilitate alignment between Regulatory Affairs, R&D, Quality, Manufacturing, Operations, Commercial teams, distributors, and external stakeholders.
- Track progress, identify risks, escalate issues when required, and drive closure of regulatory action plans.
PROFILE
Education
- Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Chemistry, Materials Science, Regulatory Affairs, or a related scientific discipline.
Professional Experience
- Demonstrated experience preparing, reviewing, or maintaining MDR Technical Documentation.
- Experience with labelling, IFUs, change control, and lifecycle maintenance activities.
- Experience supporting Notified Body reviews, audits, or technical documentation remediation projects is strongly preferred.
- Ability to analyse complex technical and scientific information and translate it into clear regulatory documentation.
- Working knowledge of medical device regulations and quality systems.
- Experience supporting international registrations and market access activities.
- Minimum 3 years of Regulatory Affairs experience within the medical device, dental device, or other highly regulated industry.
Preferred Qualifications
Experience in one or more of the following areas is considered highly desirable:
- Technical Documentation maintenance
- Knowledge of EU MDR 2017/745
- Labeling and IFU compliance
- Product change assessment and lifecycle management activities
- EUDAMED and UDI requirements
- Experience with international regulatory frameworks such as FDA, Health Canada, TGA, PMDA, NMPA, ANVISA, or similar jurisdiction is an advantage.
- Experience coordinating cross-functional projects involving Regulatory Affairs, Quality, R&D, Operations, and external partners is considered an advantage.
Personal Competencies
- Strong analytical and critical thinking skills
- Excellent attention to detail and commitment to quality
- Ability to manage multiple projects and priorities simultaneously
- Strong written and verbal communication skills
- Proactive and solution-oriented mindset
- Ability to work independently while collaborating effectively within cross-functional teams
- Strong organizational and planning capabilities
- Adaptability in a dynamic and evolving regulatory environment
Languages
- Fluent English, written and spoken, is required.
- Dutch is preferred but not mandatory.
- Additional languages are considered beneficial
