Post Market Surveillance Executive

Post Market Surveillance Executive - Medline Industries India Private Limited

Date Posted: Jan 04, 2020

Job Detail

Location:

Mumbai, Maharashtra, India
Company:

Medline Industries India Private Limited
Type:

Full Time/Permanent
Shift:

First Shift (Day)
Career Level:
Positions:

4
Experience:

2 Year
Gender:

No Preference
Degree:
Apply Before:

Jun 29, 2020

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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 Divisions 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:

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 Chteaubriant 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).

RoleOther

Industry TypeIT-Software / Software Services

Functional AreaOther

Employment TypeFull Time, Permanent

Role CategoryOther

Education

UG :Any Graduate in Any Specialization

PG :Any Postgraduate in Any Specialization

Doctorate :Doctorate Not Required, Any Doctorate in Any Specialization

Key Skills

QA Regulatory Affairs Team Leading RA

Benefits

Skills Required

Job is expired

Company Overview

Medline Industries India Private Limited

Pune, Maharashtra, India

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Medline is America’s largest provider of medical supplies and solutions, family-led for four generations. Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 pro... Read More

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