Regulatory affairs professional, database (danaher)

Roles and Responsibilities

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