Regulatory Submissions
Prepare and submit regulatory filings, including new product applications, renewals, amendments, and reports.
Ensure submissions meet regulatory authority requirements (FDA, EMA, CDSCO, etc.).
Compliance & Documentation
Maintain up-to-date knowledge of regulatory guidelines and industry standards.
Ensure internal processes, SOPs, and product documentation are compliant with regulations.
Cross-Functional Collaboration
Work with R&D, quality, clinical, and manufacturing teams to ensure regulatory requirements are integrated into product development.
Support product labeling, packaging, and advertising compliance.
Regulatory Intelligence & Strategy
Monitor regulatory changes and advise the organization on potential impacts.
Assist in regulatory strategy planning for new product launches or market expansion.
Audits & Inspections
Support regulatory audits and inspections.
Provide documentation and clarifications to regulatory authorities as needed.
Health insurance (employee + family)
Paid leaves and company holidays
Performance-based incentives or bonuses
Provident Fund (PF) and retirement benefits
Professional training and certification support (e.g., RAC)
Employee wellness and work-life balance programs
Medtronic develops, manufactures, and sells medical devices, therapies, and services for many chronic conditions. Key business areas include: Cardiovascular: pacemakers, defibrillators, stents, heart valves, cardiac ablation, structural heart de... Read More