Regulatory Affairs Associate - Dehra Dun, India - Sunfox Technologies private limited

Sunfox Technologies private limited

Verified Company

Dehra Dun, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Job description

Roles and Responsibilities:

Reviewing and interpreting regulatory requirements for medical devices and providing guidance to other departments on compliance issues.
Collaborating with other departments, such as research and development, quality, and manufacturing, to ensure that products meet regulatory requirements.
Staying uptodate with changes in regulatory requirements and communicating relevant information to other departments.
Assessing the regulatory implications of product changes and providing guidance on the approval process.
Collaborating with external consultants and regulatory bodies to ensure timely clearance or approval of products.
Maintaining and updating regulatory files, such as Device History Records and Design History Files, to ensure compliance with the latest regulations.
Communicating with the authorities regarding product compliance and providing responses to their requests for information.
Participating in internal and external audits to ensure compliance with regulatory requirements.
Keeping track of the product's regulatory status and ensuring that the products are in compliance with the regulations throughout

Competency Requirements: