Head of Risk and Compliance managing regulatory compliance and risk frameworks for a fintech scale - up. Leading risk assessments and ensuring adherence to Luxembourg and EU regulations.
About the role
- Senior Label Designer developing UDI-compliant labels for medical devices. Collaborating with cross-functional teams to ensure quality and regulatory excellence in labeling.
Responsibilities
- Manage product label and UDI data changes in compliance with relevant QMS processes.
- Collaborate with stakeholders to gather, transform, and verify accurate label content.
- Maintain and update labeling procedures to ensure regulatory compliance and operational efficiency.
- Partner closely with internal “label customers” to support departmental and business needs.
- Lead or contribute to continuous improvement initiatives in Label Development and standardization.
- Investigate and resolve non-conformance issues with internal teams and suppliers, implementing effective corrective actions.
- Support the design, testing, and implementation of labeling software tools and systems.
- Train and support end users on labeling processes and tools to promote best practices.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Quality Management, Engineering, or a related field.
- Minimum 2 years of experience in label data management, regulatory, or quality functions within a highly regulated industry (e.g. medical device, pharmaceutical, or food).
- Hands-on experience with labeling or quality software such as Prisym, Robar, Bartender, or similar.
- Proficiency in Microsoft Suite (Excel, Power BI, etc.).
- Excellent English communication skills, enabling effective collaboration with global and local stakeholders.
- Preferred: German language skills.
- Strong project management abilities and experience leading cross-functional collaboration.
- Familiarity with EU MDR, ISO 13485, FDA 21 CFR Part 820, and other global quality standards.
Benefits
- Flexible working hours
- Opportunity to work partially from the home office
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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