1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Keep in touch with international legislation, guidelines and customer practices
Keep up to the date with a company’s product range
Ensure that a company’s products comply with the current regulations.
Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
1. Well acquainted with latest ISO 13485:2016 , CE & CDSCO norms forMedical Devices all class ( Preferably cardiac)2. Having experience of preparing dossiers for varieties of countries andtheir rules and regulations.3. Must have experience of handling ISO , CE & CDSCO audits.4. Experience of ...
1 Opening(s)
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the ...