job title: regulatory digitization coordinator(resmed)

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.