Require Regulatory Affairs Senior Analyst at Danaher

Danaher takes its name from a tributary of the South Fork Flathead River in western Montana. In the early 1980s, this was the setting for the fishing trip where Steven and Mitchell Rales envisioned a new kind of manufacturing company one dedicated to continuous improvement and customer satisfaction. The root “Dana” is an ancient Celtic word meaning “swift flowing,” an apt descriptor for the nimble mindset and rapid flow of innovation that have defined Danaher for decades.

Post : Senior Analyst, Regulatory Affairs

Job Description
• Monitor and track global regulatory developments affecting IVDs, medical devices, software, AI-enabled products, and chemical/environmental compliance frameworks (e.g., FDA, EU IVDR, REACH, RoHS, CLP, PFAS, EPA).
• Perform regulatory intelligence assessments and summarize regulatory changes, identifying potential impacts to products, processes, systems, and documentation. Maintain regulatory intelligence databases, dashboards, trackers, and communication tools.
• Prepare regulatory impact assessments and support regulatory change management activities, including tracking actions, maintaining compliance plans, and facilitating implementation with cross-functional stakeholders. Develop and deliver periodic regulatory intelligence reports and presentations for management review.
• Leverage digital and AI-enabled tools to improve regulatory monitoring, trend analysis, and knowledge management processes.
• Support inspections, audits, and compliance initiatives by providing regulatory intelligence and change management documentation.

Candidate Profile
• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; Master's degree preferred. 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry.
• Working knowledge of global medical device and IVD regulations, including FDA regulations, EU IVDR, ISO 13485, and applicable regulatory guidance.
• Experience conducting regulatory assessments and translating regulatory requirements into actionable business recommendations and managing or supporting compliance-related projects in a cross-functional environment.
• Strong analytical, communication, and project management skills.
• Experience using regulatory intelligence platforms, compliance databases, or digital tools.

Additional Information
Experience : 5+ years
Qualification : Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs
Location : Bangalore, Karnataka
Kolkata, West Bengal
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September 2026