Regulatory Affairs Professional

Job Requirements

Job Duties & Responsibilities: This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Medical devices and IVD devices under Medical Device Rule 2017 and other applicable regulatory requirements in India. This position will also support in fulfilling the regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives. Job Description: Responsible to interact with local business teams and global RA teams & make applications, clarify to queries, follow up with CDSCO for obtaining regulatory licenses/ approvals for Medical devices and IVD devices as required. Perform post market surveillance compliance & reporting requirements for the registered devices. Coordinate with service & logistics teams for the Field Safety Corrective Actions implemention. To evaluate, apply & obtain approvals for the Product Change Notifications for registered devices. Support business partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to comply regulatory requirements related to Medical devices and IVD devices as required. Maintain documentation related to all above topics including progress & record trackers. Support Quality system audits of service agencies and dealers/ distributors. Keep abreast of new regulations and updates/ changes to existing regulations & requirements for the devices

Work Experience

Experience and Qualification: BPharm/ BSc/ BTech with 6-8 years experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) for IVD medical devices and IVD devices. Should have knowledge about medical device & IVD devices regulations in EU & USA, Bangladesh, Sri Lanka, Bhutan. Good communication & interpersonal skills.