MDR specialist

Dear Aspirants,

Urgent hiring!!!!

3-5 Years

Bangalore -ELECTRONICITY

budget upto 12LPA

Medical Device Reporting (MDR)

Job 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 Solutions (LS) 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.
• In addition, support the Commercial Product Quality (CPQ) department when working on post market LS product line issues.
• Provide CPQ support for LS Product Health Teams.

Requirements:

• 3-5 years of experience with Medical Device Reporting (US and Outside of the US)
• Good writing, communication and organizational skills necessary.

Location: Siemens, Healthineer

1. Total number of interview rounds. 2
2. Interview mode Virtual, Face-to-Face, or a combination of both. L1- Virtual, L2 : F2F
3. Work Mode: WFO or Hybrid Could you please confirm the expected number of work-from-office days per week? Hybrid (3 days a week, may change to 5 days depending on Business requirement,