Urgent:Quality & Regulatory Associate :Medical Devices,WorkMode-Remote

Job Title:Quality & Regulatory Associate

Work Mode: Full Remote

Department

Quality Assurance & Regulatory Affairs (QA/RA)

Job Purpose The Quality & Regulatory Associate is responsible for supporting and maintaining the Quality

Management System (QMS) and ensuring regulatory compliance of medical devices in accordance with applicable international standards and regulatory requirements, including

ISO 13485, EU MDR, US FDA, and CDSCO. The role involves active participation in audits,

regulatory submissions, and continuous improvement of quality processes.

Key Responsibilities

Quality Assurance Responsibilities

  • Support implementation, maintenance, and continuous improvement of the Quality
Management System in compliance with ISO 13485:2016.
  • Assist in the preparation, review, and control of QMS documentation including SOPs,
work instructions, forms, and records.
  • Support risk management activities in accordance with ISO 14971:2019, including
risk analysis, risk evaluation, and risk control documentation.
  • Support software lifecycle documentation and compliance activities in line with IEC
  • Participate in internal audits, supplier audits, and regulatory inspections; assist in
preparation of audit plans, responses, and corrective actions.
  • Support investigation, documentation, and closure of nonconformances, CAPAs,
and change controls.

Regulatory Affairs Responsibilities

  • Support preparation, compilation, and maintenance of regulatory submissions and
technical documentation for multiple geographies, including: Job Description - QARA

EU MDR (2017/745) Technical Documentation, and related files

US FDA Registration & Listing, 510(k) support, QMSR (21 CFR Part 820)

documentation

CDSCO (India) Device registration, licenses, and regulatory correspondence

  • Support review and maintenance of product labeling, IFUs, and regulatory claims to
ensure compliance with applicable regulations.
  • Assist in tracking and implementing regulatory changes and standards updates
applicable to medical devices and software as a medical device (SaMD).

Required Knowledge Skills:

Technical & Regulatory Knowledge
  • Working knowledge of ISO 13485:2016 Quality Management System requirements.
  • Knowledge of IEC 62304 for medical device software lifecycle processes.
  • Knowledge of ISO 14971:2019 risk management principles and application.
  • Understanding of EU MDR, US FDA, and CDSCO regulatory frameworks.
  • Familiarity with audit processes, regulatory inspections, and compliance requirements.
Skills:
  • Strong documentation and technical writing skills.
  • Good understanding of medical device lifecycle and Quality Management system
  • Ability to analyze quality and regulatory data and identify compliance gaps.
  • Strong communication, and coordination skills.
  • Ability to work collaboratively with cross-functional teams.
Experience:

Qualifications

  • Bachelors degree in Engineering, Life Sciences, Biomedical Engineering, Pharmacy,
or a related field.
  • 2-5 years of experience in Quality Assurance and/or Regulatory Affairs in the medical
device or healthcare industry.
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