Job Position: 1
Location: Bangalore & Malur need basis
Experience: 3 to 6 years
This position provides subject matter guidance. He/she works within a team of Regulatory Affairs to ensure Panacea establishes best practices in compliance with regulatory requirements.
The associate – Regulatory Affairs will be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.
Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance to all US, EU requirements as well as to corporate policies and procedures regarding submissions and other requirements for market approval of medical devices. Apply scientific principles to understanding safety and efficacy on a wide range of products.
Knowledge of various IEC, standards like 60601-1, ISO 14971 – Risk Management
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