Monisha Murali
Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices I Regulatory Strategy I Regulatory Intelligence
- Role
- Quality and Regulatory Specialist at medmix
- Location
- Hudson, NH, US
- LinkedIn followers
- 500 followers
About Monisha Murali
I am a Quality Engineer specializing in engineering documentation, CAPA management, and…
Experience
Quality and Regulatory Specialist
Apr 2024 — Present · US
Key Responsibilities:• Managed supplier quality documentation in accordance with ISO 14001, ISO 45001, and ISO 13485 standards.• Leveraged SAP, Agile, and Quentic to streamline document control, track supplier performance, and ensure compliance with global regulations.• Conducted supplier audits, evaluating compliance with regulatory requirements and driving corrective actions.• Coordinated with cross-functional teams to implement and improve supplier management processes using Babtec and Q-Manager.• Assisted in the planning, coordination, and execution of internal audits to ensure compliance with ISO 14001, ISO 45001, and ISO 13485 standards.• Supported external audits by preparing documentation, coordinating with auditors, and addressing audit findings to maintain regulatory compliance.
Education
Manipal Academy of Higher Education
MSc. Dietetics and Applied Nutrition, Foods, Nutrition, and Related Services
JOBS FOR WOMEN
Bachelor of Science, Food science and Management
Northeastern University
Master's degree, Regulatory Affairs
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