Job Description

Internal Title: Regulatory Affairs Professional

External Title: Deputy General Manager

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 IVD devices & 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 IVD devices and Medical devices regulated under Medical Device Rules 2017.
• Responsible to obtain new wholesale license of IVD devices & 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 IVD devices and 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 8-10 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 IVD and medical devices.
• Should have knowledge about IVD devices & Medical device regulations in EU & USA, Bangladesh, Sri Lanka.
• Good communication & interpersonal skills.

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Mid-level Professional

Full / Part time: Full-time

Siemens