Regulatory Affairs Professional - Gurugram | Zoek India | 20195e905aa3467f8290bc1368786bc4
Regulatory Affairs Professional
Gurugram, Haryana, India
Permanent (Full time)
- 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.
If you have further questions regarding the role then please be free to contact Pooja Kochar on ######- .