Medical Devices (US Shift)

Roles & Responsibilities
• Prepare and review Post Market Surveillance (PMS) reports for medical devices
• Author and manage PSUR, CER, PMS Reports, and Trend Reports
• Handle Clinical Safety Reporting (CSR) activities for medical devices
• Ensure compliance with EU MDR, IVDR, vigilance, and risk management requirements
• Perform data analysis and safety evaluation for post-market activities
• Coordinate with cross-functional teams for timely regulatory submissions
• Maintain documentation as per global regulatory standards and internal SOPs
• Support audits, inspections, and regulatory queries related to PMS activities

Qualification
• Any Graduate (Life Sciences / Pharmacy / Biomedical background preferred)

Experience
• Minimum 3 years of hands-on experience in PMS for Medical Devices
• Strong exposure to PSUR, CER, PMS Reports, and Clinical Safety Reporting

Skills Required
• Strong knowledge of Post Market Surveillance for medical devices
• Good understanding of EU MDR / IVDR regulations
• Experience in vigilance, risk management, and safety reporting
• Excellent regulatory writing and documentation skills
• Strong analytical and problem-solving abilities
• Ability to work independently in a US shift environment
• Good communication and coordination skills

About the Role
This role provides exposure to global medical device regulatory requirements and offers the opportunity to work on international PMS and safety compliance projects in a fast-growing regulatory environment.

Share your CV at: nitya.hird@gmail.com
Contact: 9303800841