Hi,



*Mechanical Designer (EUMDR) Mansfield, MA 6+ Months Contract *



*Job Description:  *

·         Hand on experience in Medical
Device DHF Remediation documentation.

·         Review the Problem Description and Problem type using a defined
template and identify incomplete gaps

·         Experience in Standards Assessment and Gap analysis

·         Preferable to have knowledge of Quality Management Systems based
on ISO 13485:2016.

·         Preferable to have knowledge of Risk Management Systems based on
ISO 14971:2012.

·         Experience in EU Medical Device Regulation (2017/745) & FDA 21
CFR part 820.



Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

E:  [email protected]

A:  1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

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