The Hird | Process Associate || Medical Devices | kolkata

4 weeks ago

kolkata, India The Hird Full time

Hi Applicants,


We are Hiring for the leading MNC for Medical Devices for Kolkata Location :-


Experience - 0-4 Years

Qualification - B.Tech / B.E ( Biomedical Engineer Only )

Notice Period - Immediate Joiners

Package - Upto 4 LPA

Location - Kolkata ( WFO )


PRINCIPAL RESPONSIBILITIES:


  • Writing global vigilance reports ensuring that the information is accurate and complete.
  • Timely submission of global vigilance reports to necessary authorities
  • Acting as an advisor to a team of Vigilance Reporting Specialists, motivating the team and ensuring through good leadership that defined performance outcomes are delivered.
  • Monitoring metrics and driving process improvements based on performance trends.
  • Ensuring quality customer and regulatory communications.
  • Establishing and assuring adherence to schedules, work plans, and performance requirements.
  • Collaborating with Level 3 complaint investigator to determine the need for Clinical
  • Assessment and Clinical Harm Review.
  • Responding to and collaborating with complaint investigators and PMS Clinical Experts to ensure complaint investigation results and clinical subject matter expertise is considered and documented related to regulatory reporting decision making, assessment of event.


SKILLS REQUIRED :


  • Has basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001
  • Able to write effective Medical and Technical narratives regarding the complaints.
  • Must have good computer skills & good to have skills in power BI,Track wise ,SAP,Service max.
  • Able to think critically to determine the type of questions which need to be asked together necessary information.
  • Good problem solving and analytical skills.

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