Regulatory Affairs Job at Radiometer | Pharmaceutical Sciences Graduates Apply Now
Radiometer, a Danaher operating company, is seeking a Regulatory Affairs Professional, Database for its Commercial QA/RA team. This Regulatory Affairs Job focuses on improving global healthcare by enabling fast, easy patient diagnoses by managing critical regulatory data that drives medical device compliance.
- Position: Regulatory Affairs Professional, Database
- Location: Kolkata, West Bengal, India
About The Company
At Radiometer, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Radiometer, life comes first. The Company’s vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care.
Job Overview
The Regulatory Database Professional is responsible for managing the regulatory database to ensure audit readiness, accurate records, compliant registrations, validated data, archiving, and user training/support. This Pharma Job reports to the Senior Manager Commercial QA/RA and is part of the Commercial QA/RA team and will be a remote role in India.
Job Responsibilities
- Manage and keep the Regulatory database audit-ready and maintain accurate product records.
- Handle intake of registration requests and coordinate timely follow-up actions.
- Monitor compliance progress to ensure updates are completed on time and meet regulatory standards.
- Verify accuracy of entries and archive documentation per company and regulatory procedures.
- Provide training and ongoing assistance to ensure effective and compliant database use.
Requirements
- A master’s degree, e.g., in pharmaceutical sciences, medical technology, or a similar science field, is required for the Pharma Job.
- Experience in Regulatory Affairs within the medical device or diagnostics industry.
- Proficiency in regulatory systems/tools (e.g., electronic submission platforms, document control systems).
- Familiarity with global regulatory frameworks and product registration processes within life sciences.
- Ability to interpret and apply global regulatory requirements (EU MDR, IVDR, FDA, Health Canada, PMDA, etc.)
