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R

Regulatory Affairs Project Manager

rapidai · 30+ days ago

Bangalore, India

Negotiable

Full-time

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Position Duties And Responsibilities

Assemble, distribute, store, track and retrieve information pertinent to the regulatory process, including the regulatory submissions process
Author and publish electronic submissions
Manage requests from foreign government and/or distributors as needed
Research, analyze and communicate information pertaining to the appropriate regulatory pathway for new or modified products
Provide regulatory direction to development project teams as a core team member; helps develop regulatory strategy for new products
Evaluate risk of proposed regulatory strategies; may offer solutions
Review proposed labeling for compliance with applicable global regulations
Review and evaluate promotion and advertising material for compliance with applicable regulations
Review proposed product changes for impact on regulatory status of the product
Communicate with regulatory and governmental agencies
Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams
Assist quality team – including but not limited to training and document control
This position does not have direct reports.
Perform any other related activites assigned by reporting manager.

Education, Experience, And Qualification

Strong writing, communication, and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of overall business environment, the SaMD industry, and the marketplace
Ability to learn and stay abreast of regulations pertinent to medical devices
Ability to building relationships between Regulatory Affairs and other areas of the
organization: ability to communicate effectively at all levels
Knowledge of FDA, EU, and other regulatory body regulations
Ability to identify risk in Regulatory strategies
Strong problem-solving skills
Bachelor’s degree required
A minimum of 2-5 years of experience in SaMD or medical device industry
Regulatory Affairs Certification (US or EU) preferred

•

Last updated on Sep 12, 2024

About the company

R

rapidai

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