Desired Candidate Profile
Should have Knowledge on ISO 13485 and Medical Device Directive (MDD);
ISO 14971, Risk Management Process;
IEC 60601, basic Safety standard, particulars and collaterals;
Safety and (environmental) legislations of various countries as applicable
Supports R&D projects and guides regarding approbation activities.
Describes the regulatory activities in a R&A plan .
Product Test Records (certifiable items) for Initial reporting (e.g. USA, Canada)
Establishes & maintains Regulatory & Approbation
Medical , healthcare , Regulatory , Quality & Regulatory , Q&R , ISO 13485 , MDD , Medical Device Directive , R&A , Approbation , Risk analysis, Government Affairs, Regulatory Affairs
Fortune 500 Healthcare MNC
Naukri.com - 2 years ago