Are you passionate about regulatory affairs and digitization in the healthcare industry? ResMed, a global leader in digital health technologies and medical devices, is seeking a Regulatory Digitization Coordinator to join our dynamic team in Bangalore. This is an exciting opportunity to contribute to the digitization of regulatory processes, ensuring compliance and efficiency in a fast-paced, innovative environment.
Key Responsibilities
- Regulatory Knowledge:
- Demonstrate a strong understanding of regulatory functions, particularly in the medical device or pharmaceutical industry.
- Stay updated on global regulatory requirements and guidelines.
- System Expertise:
- Utilize Regulatory Information Management Systems (RIMS) and Unique Device Identification (UDI) systems (e.g., EUDAMED, GUDID) to manage and maintain regulatory data.
- Data Preparation and Maintenance:
- Ensure the accuracy and compliance of regulatory data within RIMS/UDI systems.
- Regularly update and maintain regulatory databases.
- Data Analysis:
- Conduct in-depth analysis of regulatory data to identify gaps and areas for improvement.
- Provide actionable insights to enhance data quality and compliance.
- Global Coordination:
- Collaborate with global team members to review and validate RIMS/UDI data.
- Offer guidance and support to ensure consistency and accuracy across regions.
- Transition Support:
- Assist global teams in transitioning to RIMS/UDI systems, ensuring a seamless and efficient process.
Qualifications
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
- 3-4 years of relevant industry experience, preferably in regulatory affairs within the medical device or pharmaceutical sector.
- Proficiency in RIMS and UDI systems (e.g., EUDAMED, GUDID).
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to work effectively in a global team.
- Detail-oriented, highly organized, and capable of managing multiple priorities.
Preferred Qualifications
- Experience with regulatory submissions and compliance processes.
- Familiarity with technology/tools that support regulatory functions.
- Ability to work independently and as part of a collaborative team.
Why Join ResMed?
At ResMed (NYSE: RMD, ASX: RMD), we are committed to making the world a healthier place. By joining our team, you’ll be part of a culture that values innovation, excellence, and inclusivity. We empower our employees to not only meet their goals but also to create new ones, fostering a workplace where individual expression and diverse ideas thrive.
Our digital health technologies and cloud-connected medical devices are transforming care for people with sleep apnea, COPD, and other chronic diseases. With comprehensive out-of-hospital software platforms, we support healthcare professionals and caregivers in delivering better care, improving quality of life, and reducing healthcare costs in over 140 countries.
About ResMed
ResMed is a global leader in digital health technologies, dedicated to improving the lives of millions of people worldwide. Our innovative solutions treat and keep people out of the hospital, enabling them to live healthier, higher-quality lives. From sleep apnea to chronic respiratory conditions, our products and services are at the forefront of healthcare innovation.
