Regulatory Digitization Coordinator Role – at ResMed in Bangalore, Apply Now!
ResMed, a global leader in digital health and connected medical devices, is looking for a detail-oriented and tech-savvy Regulatory Digitization Coordinator to join their team in Bangalore. If you have a background in life sciences, regulatory affairs, and a passion for digitization and compliance, this role offers the perfect blend of regulatory expertise and data management.
Job Posting: Regulatory Digitization Coordinator
Job requisition Id: JR_040321
Locations: Bangalore, India
Key Responsibilities for Regulatory Digitization Coordinator Role:
- Regulatory Knowledge: Possess a strong understanding of regulatory functions preferably for medical devices or drugs.
- System Expertise: Demonstrate proficiency in using Regulatory Information Management Systems (RIMS) and/or UDI system (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 as Regulatory Digitization Coordinator.
- 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 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 (regulatory information management systems) and/or UDI data management preferred for Regulatory Digitization Coordinator.
- 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.
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