MDR specialist

GSR Business Services; Bengaluru; Hybrid; INR 1,080,000 - 1,320,000; Full time

Job summary

Siemens Healthineers in Bengaluru is seeking an experienced MDR professional to assess safety complaint escalations and determine MDR submissions in line with 21 CFR 803. You will file MDRs and coordinate with the EU Authorized Representative or Regional Unit, while supporting cross-functional teams on related reporting and CPQ activities.

The role requires 3-5 years of MDR experience, strong communication and writing abilities, and a hybrid work arrangement with potential travel as needed.

Qualifications

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

Responsibilities

• Evaluate safety complaint escalations and decide on MDR submissions.
• File MDRs and communicate with EU Authorized Representative or Regional Unit as needed.
• Review and close potentially adverse events related to Laboratory Solutions (LS) product lines.
• Support MDR/MDVR/MDPR-Canada reporting and trending activities.
• Assist CPQ department with post market LS product line issues.

Skills

MDR knowledge

Medical writing

Communication

Organizational skills

Job description

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,