Regulatory Digitization Coordinator Job at ResMed – Apply Now
Are you passionate about regulatory affairs and digital transformation? ResMed is looking for a Regulatory Digitization Coordinator to support global regulatory data management. In this role, you’ll ensure compliance, maintain data accuracy within Regulatory Information Management Systems (RIMS) and UDI systems like EUDAMED and GUDID, and collaborate with international teams. If you have experience in regulatory affairs and a keen eye for detail, this could be your next career move!
Job Posting: Regulatory Digitization Coordinator
We are seeking a highly motivated and detail-oriented individual to join our Regulatory Digitization team at ResMed. 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 for Regulatory Digitization Coordinator:
- Regulatory Knowledge: Possess a strong understanding of regulatory functions preferably for medical devices or drugs.
- System Expertise: Demonstrate proficiency in using RIMS and/or UDI systems to manage regulatory data.
- Data Preparation and Maintenance: Prepare, maintain, and update regulatory data within the RIMS/UDI system.
- 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.
- Transition Support: Assist global team members with their RIMS/UDI transition plans.
Qualifications for Regulatory Digitization Coordinator:
- 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 and/or UDI data management.
- Excellent analytical, problem-solving, communication, and interpersonal skills.
- Detail-oriented, highly organized, with the ability to manage multiple tasks and priorities.
Preferred Qualifications for Regulatory Digitization Coordinator:
- Experience with regulatory submissions and compliance processes.
- Familiarity with using different technology/tools to support regulatory functions.
- Ability to work independently and as part of a team.
Keywords: Regulatory Digitization Coordinator, ResMed, Job, Regulatory Affairs, Regulatory Information Management Systems, UDI, Medical Devices, Pharmaceutical Industry
