Company: Nasan Medical Electronics Pvt Ltd
Department: Medical Devices
This is a full-time on-site RA Executive role located in Pune at NASAN Medical Electronics Pvt. Ltd. The RA Executive will be responsible for regulatory affairs activities, ensuring compliance with regulations, preparing and submitting regulatory submissions to CDSCO, and communicating with regulatory agencies.
Experience in Complaint handling, PMS, and adverse event analysis in active medical devices, especially cardiology-centric devices and ventilators.
Risk management
SDLC
DMF
well aware of MDQMS ISO 13485, IMDR2017,
Qualifications
Knowledge of regulatory affairs and compliance
Experience in preparing and submitting regulatory submissions
Strong attention to detail and analytical skills
Effective communication and interpersonal skills
Ability to work independently and collaboratively within a team
Bachelor's degree in a relevant field
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