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PMS Executive Regulatory & Quality Affairs Team

4.00 to 6.00 Years   Pune   25 Mar, 2020
Medline Industries India Private Limited
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

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).
,

Keyskills :
medical devicesquality systems pack officereport writing regulatory affairsregulatory requirements quality auditeducational qual

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