ra / qa in bengaluru / bangalore

posted
contact
randstad india
position type
permanent
apply now

posted
location
bengaluru / bangalore
function
Pharma, healthcare & lifesciences
position type
permanent
experience
5
reference number
65581
contact
randstad india

job description

ra / qa in bengaluru / bangalore

Regulatory Affairs

  • Responsible for preparation, Compilation & Review the technical documents as per MDR-17 & Drugs and Cosmetics Act & Rules and various guidelines published by CDSCO to obtain the Import license for the various Medical Devices.
  • Responsible for check/analyse and implementation of regular updates on scientific information provided by Drug agencies of India to maintains the strict regulatory compliance as per the latest regulations.
  • Responsible for coordination with liaising with Drug Regulatory Agency of India i.e. CDSCO , State FDA, for the submission and follow up of an application.
  • Should be aware about the Medical Device Labelling and responsible for compliance with India Specific Requirements.

Quality Assurance (Post Market Surveillance): Complaint Handling Process:

  • Should be aware about the Indian guidelines for reporting AE/SAE complaints.
  • Responsible for complaint handling and related process management, which includes the complaint Initiation, Evaluation, Investigation, and Coordination with internal as well external colleagues.
  • Responsible for evaluation and assessment of any complaint/feedback from reporting point of view to authority.
  • Responsible for report the SAE/AE to CDSCO or its authorized centre.

Recall and FCA

  • Should be aware about the Indian and IMDRF countries guidelines about the Recall and FCA.
Responsible for coordination, assessment, monitoring, and management of FSCA/Recall as per timeline and reporting of the same to CDSCO.

skills

Sales . Marketing

qualification

Any