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 drugsSystem 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 yearsBachelor'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!