[Hiring] Staff Regulatory Affairs @Danaher Corporation

Role Description

The Staff Regulatory Affairs is responsible for driving compliance through regulatory change and regulatory intelligence activities including but not limited to identification, interpretation, assessment, and project management of changes. The purpose of this role is to maintain compliance with regulatory requirements on products and business systems and avoid audit observations and shipping delays. This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Quality and Regulatory affairs team and will be fully remote.

In this role, you will have the opportunity to:

• Monitor and analyze global regulatory intelligence across:
  • IVD and medical device regulations (e.g., EU IVDR, US FDA regulations and guidance)
  • AI/Software regulations
  • Chemical and environmental regulations (e.g., EU REACH, RoHS, PFAS, EPA, EU CLP requirement)
• Develop detailed assessments of regulatory changes, providing actionable insights and impact analyses for internal stakeholders.
• Create business cases for regulatory-driven changes, including cost, resource, and timeline impact for compliance activities.
• Support global regulatory strategy development by providing intelligence-driven recommendations.
• Maintain regulatory intelligence repositories, dashboards, and communication tools.
• Prepare and deliver regulatory intelligence briefings, cross-functional reports, and executive summaries.
• Leverage AI-enabled tools to automate horizon scanning and early detection of regulation changes.
• Lead compliance gap analyses and risk assessments to proactively identify areas of regulatory exposure and develop mitigation plans in partnership with Quality and Legal teams.
• Ensure alignment with internal SOPs and global regulatory standards.

Qualifications

• Master’s degree in life sciences, engineering, or related field; advanced degree preferred.
• 10+ years of experience in regulatory affairs or regulatory intelligence within the IVD/medical device industry.
• Strong knowledge of global IVD regulations including FDA, EU IVDR, ISO 13485, ISO 20916, and related standards.
• Demonstrated experience managing regulatory compliance programs, including compliance tracking systems, and audit readiness activities.
• Experience implementing regulatory intelligence systems or digital tools.
• Experience with AI/software or chemical/environmental regulations strongly preferred.
• Experience interacting with regulatory agencies or notified bodies is a plus.

Requirements

• Previous experience in a regulatory intelligence role handling gap assessment and/or coordinating remediations is a plus.

Benefits

• Comprehensive, competitive benefit programs that add value to our lives.
• Health care programs and paid time off.
• Flexible, remote working arrangements for eligible roles.