Regulatory Affairs Professional, Database

About Danaher

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 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.

Job Summary

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.

Key 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

• 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.).

Preferred Qualifications

• 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.