Anu Mohan

Regulatory Affairs Specialist with a total of 14 years of experience managing product regulatory assessments, regulatory submissions, regulatory product /country compliance documentation, and global product registrations. Proven expertise in performing regulatory assessments for New product development, Changed/maintenance product lines, interpreting complex regulatory requirements, developing submission strategies, and ensuring timely product approvals across multiple markets. Skilled communicator with a strong ability to liaise between cross-functional teams and regulatory authorities.

Exhibited leadership abilities by leading a regulatory team. Notable team management and analytical skills.

Regulatory Affairs professional at Siemens Healthineers

• Regulatory Strategy & Compliance
• Global Product Registration & Submissions

(EU MDR, FDA, NMPA, TGA, CDSCO, HSA, Health Canada, MFDS, MDA, MOH (Rest of World))

• Software Product Life Cycle Management expertise
• Quality Management Systems (QMS)
• Regulatory Risk Assessment
• Labeling & Documentation Control
• Post-Market Surveillance
• Cross-Functional Leadership

Btech in Electronics and Communication Engineering

MBA in General Management