Submission of Module 2-3 Variation Filing, Responding Regulatory Queries, Literature Clinical Data
*preparation & Registration of Dossiers as per Country Guidelines and Checklist
*review of Product Development Report, Specifications
Strong Ethics and Integrity.
knowledge in Ce Marking and Fda
iso 13485, Documentation
strong Technical/functional Knowledge.
4 -8 Years of Experience in Medical Devices
engineering / Be / Biomedical/electronics
ecg, Patient Monitors, Multipara ...
JD of Regulatory Affairs:-
1. Level- GM
2. Age Group : 40-45 Years
3. Qualification-Engineering with MBA (finance)/CA with LLB
4. Experience-At least ten years in working Power Sector preferably in Commercial and Regulatory matters. Knowledge ...
Key Skills : general manager,senior general manager,regulatory officer
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science co...
Key Skills : drug regulatory affair,regulatory affair,legal officer
RS1,25,000 To 2,50,000South Delhi, West Delhi, Delhi
- Preparation of dossier in CTD/ACTD format, Analytical skills for evaluating technical documents.
- Communicating with the different department of Manufacturing Unit (QA, QC,Production etc)
- Handling of NOD / resolving query
- Preparation and compilation of Module 2, 3, 4 and 5 for the regulated markets (Europe/Australia/Canada) in CTD/eCTD format.
- Handling queries on Quality, Clinical, Non-clinical and Bio-equivalence parts received from the different regulatory auth...
To make calls, emails to higher executives (Like Purchase Head, VP, Directors. etc.)
To be able to achieve monthly financial targets
To meet with the clients, presenting the business proposal
To be able to handle the customer queries
To be able t...
Key Skills : business development executive,purchase head,procurement specialist,purchase officer,purchase...
Report and analayse regulatory policy
2. Interact with regulator on company issues and regulations
3. Respond to regulator on consultation papers
4. Respond to regulator on consumer complaints received from them.