Sr. Manager- Regulatory affair - Healthcare Division
PMS Consulting - Mumbai, Maharashtra
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
Job Description

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

Keywords:
Medical , healthcare , Regulatory , Quality & Regulatory , Q&R , ISO 13485 , MDD , Medical Device Directive , R&A , Approbation , Risk analysis, Government Affairs, Regulatory Affairs

Company Profile

Fortune 500 Healthcare MNC
Contact Details

Company Name:
PMS Consulting

Website:
http://www.pmsconsulting.in

Address:
Not Mentioned

Email Address:
jobs@pmsconsulting.in

Telephone:
Not Mentioned

Reference ID:
salespms@airtelmail.in

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