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Regulatory Affairs Professional

3 months ago


Gurgaon, Haryana, India Siemens Healthineers Full time

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 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.
  • 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 810 years' experience of premarket & 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