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.

Responsibilities

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

Editors Note: Thermo Fisher Scientific Job, Thermo Fisher Scientific Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.

LEAVE A REPLY

Please enter your comment!
Please enter your name here