Thermo Fisher Scientific - Pharma Regulatory Affairs Specialist Vacancy

Thermo Fisher Scientific Job – Pharma Regulatory Affairs Specialist 

Thermo Fisher Scientific job opening 2022. Pharma job opening 2022, Chemistry specialist job opening 2022. B Pharma job vacancy 2022. Regulatory Affairs Specialist. Regulatory Affairs Specialist job opening 2022, Intrested and eligible candidates may check out all the details on the same below:

Job Title: Regulatory Affairs Specialist

Job ID: 195545BR

Location: Bangalore, India

Elibiglitt Criteria:

  • Bachelor’s degree or higher degree in Engineering, Pharmacy, Sciences, or Medicine.
  • Over 4-8 years of relevant experience of premarket & post-market work on compliance to Medical Device Rules (MDR) 2017 governed by the Central Drug Standard Control Organization (CDSCO) for IVD & other medical devices.


This position supports the regulatory lead of LSLPG, GSG and BPG India business.

  • Compilation and review of the registration application, online (Sugam portal)/hard copy submissions to MD/IVD sections of CDSCO (Central Drug Standard Control Organization), New Delhi.
  • Prepare and submit regulatory submissions to the Authorities in South Asia and lead type test/clinical studies where needed in support of the product filings.
  • Getting the product change notifications implemented for LSLPG, GSG, and BPG products.
  • Preparation, verification & maintenance of various documents like device master file, site master file, and technical file as per requirements of various countries’ regulatory body like CDSCO, CE-MDR, USFDA etc.
  • Following up with CS team to get the field safety corrective actions implemented for LSLPG, GSG, and BPG products.
  • Support Post Market Surveillance of regulated products in India. Work with cross-functional teams, operations, and customers to resolve and implement corrective and preventive actions resulting from technical complaints.
  • Applying Duel Use NOC for India customs clearance.
  • Liaison with Authorities /officials to ensure timely approvals & availability of valid licenses.
  • Regulatory liasioning and follow up with CDSCO office for the status of applications and for any new update regarding our registered products.
  • Teleconferences with global affiliates to process and clarification on documents for ease of applications to be submitted as CDSCO.
  • Support LSG Indian Plant QMS/GMP and implement regulatory affairs activities.
  • Participate in company regulatory/quality audits and assist, as needed.
  • Other tasks assigned by the line manager.

Apply Online

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