Job opporunity for Regulatory affairs

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded in various domains in the industry and to contribute to the growth of the company. The vision is to build strong medical device portfolio in the regulated markets across the world, where the regulatory function plays a crucial role in this development. The Regulatory Affairs Specialist reports to the site head in India. The work is with domestic and international focus and performed in close cooperation with several international development partners and manufacturers.

Roles & Responsibilities:

? The individual will be working on regulatory requirement of Medical devices and Distribution in various markets

? Coordinate successful submissions and approval of all medical device approval applications with various regulatory authorities worldwide

? Keep up-to-date with changes in regulatory legislation and guidelines for medical devices across various markets

? Write comprehensible, user-friendly, clear product information leaflets and labels

? Review and report overall quality status to the management team

? Use a variety of specialist computer applications

? Explain regulations, policies, or procedures for medical device fillings

? Maintain data in information systems or databases

? Evaluate applicable laws and regulations to determine impact on company activities

? Provide technical review of data or reports

? Advice the operations and business team on applicable regulatory requirements, project specific regulatory issues as assigned.

? Act as back-up for contact with Regulatory Agencies as needed.

? Draft cover letters for Regulatory Agency communication.

? Assist with timely availability of submission documents and ensure that all document components are in place on time.

? Draft and review some document content (depending on level of regulatory knowledge/expertise).

? Understand submission details and liaise with Submission Management.

? Review of submission documents to ensure compliance with regulatory requirements.