Job Description

:Internal Title: Regulatory Affairs ProfessionalPosition SummaryThis 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.:

• 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.

• 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.

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