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Regulatory Affairs Specialist Jobs in Pune - Medline India

CW
Regulatory Affairs Specialist
Medline India
Medline India
Last Date 28 Feb 2021
This Job is Expired

Medline India - Job Details

Date of posting: 28 Dec 20
About Medline

Description du poste

Medline is America's largest privately held national manufacturer and distributor of health care supplies and services. Today, Medline manufactures and distributes more than 550,000 medical products, encompassing medical-surgical items and one of the largest textile lines in the industry. With 17 manufacturing facilities worldwide and over 25 joint venture manufacturing plants worldwide, along with 45 distribution centers in North America and 50 throughout the world, Medline posted $ 13.9 billion revenue last year. Medline is ranked #27 in Forbes 2019 list of America’s private companies.

Medline Industries India Pvt. Ltd. is engaged in providing offshore business support services to Medline Industries Inc. & its global associate companies in the area of Information Services, Finance & Business processes Management. Medline Industries India Private Limited was setup in 2010 in Pune, India and today we are proud team of 700 plus associates supporting Medline’s healthcare vision across USA, Europe & other International regions.

Why Join Medline
  • A direct, full-time employment in a large, stable, rapidly growing and yet profitable company.
  • Privately owned company with no public debts.
  • No ill effects of recent downturn/recession.
  • First-rate compensation and benefits package.
  • Genuine individual growth potential in this new establishment.
  • Open door and highly ethical work culture, with due accountability.

Requirements

Job Description: 

This position is responsible to assists the Regulatory Affairs Department for ensuring regulatory compliance with the requirements set by the respective regulatory bodies in Middle East and Africa region, including support to product quality complaints for the Middle East and Africa region. The position reports to the RA team in USA and senior management in India.

Required Skills
  • Experience in Medical Device Registration & Submission for MEA countries is a must.
  • Knowledge of applicable laws, which regulate MEA region medical device registration, is a must.
  • Expertise in EU MDR 2017/745 regulation is a must.
  • Knowledge & understanding of GHTF/IMDRF/GCC guidelines is added advantage.
  • Good understanding of ISO 13485:2016 & QMS documentation, certification is added advantage.
  • Experience in 510K submission is added advantage.
  • Familiar with device design, manufacturing and testing in order to understand the technical reports for product registration dossier submission.
  • Very good written and oral communication in English.
  • Strong technical writing skills.
  • Able to work with minimal supervision.
  • Action-oriented, strong ability and willingness to learn new things quickly.

Responsibilities
  • Maintain existing and develop new technical/design dossiers by acquiring, reviewing, and updating related documentation to support registration of global products in MEA regional countries.
  • Develop registration strategies and coordinate, implement, execute, control, and complete product registrations in all MEA regional countries.
  • Support communication with agents and distributors in the MEA region and countries.
  • Ensure that MEA regulatory requirements are fulfilled, including development and review of summary technical information (such as a STED),Essential Principles checklists, lists and evidence for applicable international standards or guidance documents, risk analysis, test reports obtained from third parties),clinical evaluation, and other requirements as applicable to specific product families and country regulations.
  • Responsible for reviewing and advising on country-specific labeling
  • Responsible for the maintenance and archival of approved documents in appropriate retention servers.
  • Track the product registration listings to keep the approvals up to date; highlight any product registration listing that are going to expire and support renewal processes.
  • Monitor and track the product quality complaints for the MEA Region.
  • Support ad hoc requests from distributors/ sales on product information (for example: technical information, vendor information, position papers, etc.).
  • Identify and respond to new or revised regulatory requirements; perform including regulatory gap analyses.
  • Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Quality Systems, Quality Audits, other international projects and requests, etc.).
  • Respond to regulator questions on submissions and product registration.

Work Experience
  • 5 to 7 years.

Educational Qualification
  • M. Pharmacy/ B.E. Biomedical / B.E. Mech.

Job Summary

Job Type : Full Time
Job Category : Diploma,Tech Support
Hiring Process : Face to Face Interview
Who can apply : Experienced (3+ yrs)

About Medline India

Medline India
This Job is Expired
This posting is done directly & exclusively on Freshersworld.com. We do not entertain any unsolicited calls or enquiries from any consultants, other portals or TPOs. Notice: This recruitment is FREE. if the recruiter charges any fees, please write us info@freshersworld.com
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