Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology
At Radiometer, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. 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. Our 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. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Database Professional is responsible for managing regulatory database to ensure audit readiness, accurate records, compliant registrations, validated data, archiving, and user training/support.
This position 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.
In This Role, You Will Have The Opportunity To
- 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.
The Essential Requirements Of The Job Include
- Master's degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology, or similar science field.
- 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.)
Travel, Motor Vehicle Record & Physical/Environment Requirements:if applicable for role
- Ability to travel occasionally to meet the team located in different areas of Europe
It would be a plus if you also possess previous experience in:
- Familiarity with commercial product lifecycle strategies and market access planning
This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team.
This job is also eligible for bonus/incentive pay.
Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
