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Regulatory Affairs Professional

Zoek Pin Gurugram, Haryana, India

Permanent (Full time)

Job Description

  • Responsible for making applications, clarifying to queries, registration of products
  • following up with CDSCO for import license of IVD devices and medical devices regulated under medical device Rules 2017.
  • following up with CS team to get the field safety corrective actions implemented for healthineers products.
  • Getting the product change notifications implemented for healthcare diagnostics products.
  • Performing quality system audits of suppliers and business partners. Supporting zone countries like Bangladesh, Sri Lanka, Nepal & Maldives for regulatory requirements related to IVD products.
  • Knowledge of regulatory practices related to manufacturing of IVD and medical devices .

Experience and Qualification :

Regulatory professional (GeneralManager) – B-Pharm/ M-Pharm with 8-10 years experience of pre market & postmarket work on compliance to Medical Device Rules(MDR) 2017 governed by CentralDrug Standard Control Organization (CDSCO) for SHPL's IVD & othermedical devices.

Contact

If you have further questions regarding the role then please be free to contact Pooja Kochar on ######- .

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