Regulatory Digitization Coordinator

We are seeking a highly motivated and detail-oriented individual to join our Regulatory Digitization team. The successful candidate will be responsible for coordinating regulatory digitization efforts, maintaining regulatory data within the Regulatory Information Management System (RIMS) and/or UDI system (e.g. EUDAMED , GUDID ) and collaborating with global team members to ensure data accuracy and compliance.

Key Responsibilities:

• Regulatory Knowledge: Possess a strong understanding of regulatory functions preferably for medical devices or drugs
• System Expertise: Demonstrate proficiency in using RIMS (Regulatory Information Management Systems) and/or UDI ( e.g. EUDAMED , GUDID) to manage regulatory data.
• Data Preparation and Maintenance:  Prepare, Maintain and update regulatory data within the RIMS/UDI system, ensuring accuracy and compliance with regulatory requirements.
• Data Analysis: Perform thorough analysis of regulatory data to identify gaps and areas for improvement.
• Global Coordination: Coordinate with global team members to review and validate their RIMS/UDI data, providing support and guidance as needed.
• Transition Support: Assist global team members with their RIMS/UDI transition plans, ensuring a smooth and efficient transition process.

Qualifications:

• Relevant industry experience of 3-4 years
• Bachelor's degree in a related field (e.g., Regulatory Affairs, Life Sciences, Pharmacy).
• Proven experience in regulatory affairs, preferably within the medical device or pharmaceutical industry.
• Understanding of regulatory requirements and guidelines for medical devices or drugs.
• Proficiency in using RIMS (regulatory information management systems) and/or UDI data management.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to work effectively with global teams.
• Detail-oriented and highly organized, with the ability to manage multiple tasks and priorities.

Preferred Qualifications:

• Experience with regulatory submissions and compliance processes.
• Familiarity with usage of different technology/tools to support regulatory function.
• Ability to work independently and as part of a team.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!