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:
    other
  • Positions:
    10
  • 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
Education
Any Graduate in Any Specialization
Post Graduation Not Required

Benefits

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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