PMS Executive Regulatory & Quality Affairs Team - Medline Industries India Private Limited

Date Posted: Jan 04, 2020
54 days ago
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Applied : 500
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Job Detail

  • Location:
    Mumbai, Maharashtra, India
  • Company:
  • Type:
    Full Time/Permanent
  • Shift:
    First Shift (Day)
  • Career Level:
  • Positions:
  • Experience:
    2 Year
  • Gender:
    Male / Female
  • Degree:
    ME/M.Tech, BE/B.Tech
  • Apply Before:
    Jun 30, 2020

Job Description

  • Assists the Regulatory Affairs Dept. for ensuring compliance with the requirements set by the EU Medical Device Regulation (MDR 2017/745) and other regulatory bodies.
  • Supports the development of internal QA/RA systems and procedures.
  • Reports to the Team Lead - Regulatory & Quality Affairs at Medline India.


Main activities :


  • Creation of medical devices trend reports summarizing the results and conclusions of the analysis of the post - market surveillance data for European market.
  • Writing & periodic review of PMS plan and report for class I devices.
  • Writing & review of periodic safety up - date reports (PSUR) for Medline Class IIa and IIb Medical Devices for European market.
  • Provide monthly reports to the different Medline Division s on complaint trending.
  • Provide analysis of vigilance data for European market.
  • Provide trending reports of reported incidents and ensure recall reports are compiled.
  • Prepare monthly supplier score cards.
  • Involve in development of procedures related to Post Market Surveillance activity.


Secondary activities :


  • Maintains regulatory knowledge of European regulations within Medline India in Pune.
  • Analysis and Development Cost of Quality (COQ) reports.
  • Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Supplier Change Control, Quality Systems, Quality Audits, etc.).


Qualifications - Duties :


  • Experience within a Medical Device industry with a Quality background.
  • Knowledge of ISO13485.
  • Understanding of regulatory requirements of European Medical Device Regulation (EU MDR 2017/245).
  • Well organized, rigorous, autonomous
  • Good technical report writing skills.
  • Good level of English (oral and written): able to communicate with the RA team located at Ch teaubriant - France and Kleve Germany and QA team in Shanghai.
  • Good computer skills: Access , pack office and excel
  • Knowledge of QAD, Microstratergy and/or Tableau soaftware is added advantage.

Experience -

  • 2 - 5 years

Education Qualification -

  • Life science background, B. Pharm/ M. Pharm. Preferable or M.Sc (Biostatistics).
Full Time, Permanent
Drug Regulatory Affairs/Documentation
Any Graduate in Any Specialization
Post Graduation Not Required


Skills Required

Company Overview

Pune, Maharashtra, India

Help us drive the healthcare solutions needed for today and tomorrow. As both a manufacturer and distributor of medical supplies and clinical programs, we help healthcare providers improve patient outcomes and reduce costs through clinical and finan... Read More

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