Regulatory Affairs Professional

Internal Title: Regulatory Affairs Professional

Position Summary

This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be sold in India.

This position will also ensure compliance to the applicable regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives.

Job Description:

• Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of Medical devices regulated under Medical Device Rules 2017.
• Responsible to obtain new wholesale license of medical devices from state FDA, renew/amend existing license as required.
• Perform post market surveillance compliance & reporting for the registered devices.
• To evaluate, apply & get the Product Change Notifications approved for registered devices.
• Coordinate with CS & logistics team to get the Field Safety Corrective Actions implemented for devices.
• Support buss. partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to fulfill regulatory requirements related to Medical devices.
• Perform Quality system audits of suppliers, service agencies and business partners.
• Maintain documentation related to all above topics including progress & record trackers.
• Keep abreast on updates/ changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.

Experience and Qualification:

• BPharm/ MPharm/ BTech/ MTech/ BSC/ MSc with 3 -6 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) & state FDA for diagnostic imaging & therapy medical devices including Software medical devices. 
• Should have knowledge about Medical device regulations in EU & USA, Bangladesh, Sri Lanka. 
• Good communication & interpersonal skills.