Quality Professional - Bengaluru, India - Siemens Healthineers

Siemens Healthineers

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Evaluate safety complaint escalations, assess and make decisions on medical device reporting [Medical Device Report (MDR)-MedWatch Form 3500A], in accordance with 21 CFR 803, and documenting those decisions.

File MDRs when needed and communicate (as appropriate) to the EU Authorized Representative or Regional Unit.
Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to Laboratory Diagnostics (LD) BA product lines.
Provide support in all areas associated with Medical Device Report (MDR) / Medical Device Vigilance Report (MDVR) / Medical Device Problem Report (MDPR-Canada) reporting and trending.

Organization:
Siemens Healthineers

Company:
Siemens Healthineers India LLP

Experience Level:
Experienced Professional

Full / Part time:
Full-time