Antal International Network Jobs 2022 Apply Online Quality Assurance, Regulatory Affairs Manager vacancy Jobs in Across India - News

Antal International Network Jobs 2022 Apply Online Quality Assurance, Regulatory Affairs Manager vacancy Jobs in Across India was updated on 29th August 2022​, Candidates can apply online @fresherslive.com

Last Updated: Aug 29, 2022 05:10 AM | FL Admin

Antal International Network Jobs 2022 Apply Online Quality Assurance,  Regulatory Affairs Manager  vacancy Jobs in Across India - News
Quality Assurance, Regulatory Affairs Manager Job Vacancy in Across India apply Antal International Network Jobs 2022

Antal International Network Careers 2022 Notification Overview

JOB DETAILS

Company Name
Antal International Network
Job title
Quality Assurance, Regulatory Affairs Manager
Role
Education
Location
Experience
3-6 Years
Salary
Not Mentioned

Job Profile



Job Description

Designation: Quality Assurance,Regulatory Affairs Manager
Location: Bengaluru, Karnataka
Industry: Medical Device
Experience: 3+ years in class II & III Medical Device
Reports To: GM - Manufacturing
About the company:
Client with a decade of core expertise in manufacturing of X ray equipment's, has expanded its capabilities - single detector solutions, dual detector solutions, floor mounted systems, ceiling suspended systems, floor to ceiling systems, mobile system, line powered and Battery operated systems and a bevy of ranges in C arm's .
KEY RESPONSIBILITIES:
  • Responsible for Establishment and Implementation of QMS as per ISO 9001, ISO 13485, CE , FDA etc. and other Regulatory approvals and working on Class II , III medical devices.
  • In depth understanding of ISO 13485, CFR 820, EU MDR, CE & ISO 14971, GMP, preferred certified Internal Auditor.
  • Responsible to get the registration of medical devices in India and other regulatory bodies.
  • Experience in QMS, SOP, IQ, PQ, OQ, CE submissions, other global regulatory requirements.
  • Responsible as Management Representative for conducting audits internally and externally with sub - contractors, MRM review on quality systems, processes, and products to ensure compliance with regulations.
  • Developing regulatory strategies, preparing CE / US FDA submission, providing documentation for international submissions, evaluating proposed product changes for regulatory impact, and preparing necessary documentation.
  • Assist in risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
  • Review Design History Files and Technical Files for conformance to applicable regulatory requirements. Maintain Regulatory Affairs product files to support compliance with regulatory requirements and Approvals to introduce new and modified products to the market.
  • Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications.
  • Participate in the development of corrective & preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings.
  • Keeps current on global directives, harmonized standards, procedures and communicates changes that may affect R&D and cross - functional team.

REQUISITE SKILLS:
  • Understanding of ISO 13485, CFR 820, EU MDR, CE & ISO 14971, GMP, preferred certified Internal Auditor.
  • Knowledge in QMS, SOP, IQ, PQ, OQ, CE submissions, other global regulatory requirements.
  • Team Building.
  • Excellent communication skills.
  • Strong organizational skills with a problem-solving attitude.

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OTHER DETAILS

Key skills
Quality Assurance
Industry
Recruitment/ Staffing/ RPO
Summary
Job Description Designation: Quality Assurance,Regulatory Affairs Manager Location: Bengaluru, Karnataka Industry: Medical Device Experience: 3+ years in class II & III Medical Device Reports To: GM - Manufacturing About the company: Client with a
Last Date
2022-10-26

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