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Post Market Quality Assurance Research

Natus Medical Incorporated
Natus Medical Incorporated
3-4 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Post Market Quality Assurance Research – Natus Medical (Bangalore, India)

📍 Location: Bangalore, India
📌 Global Function: Quality Assurance
📅 Requisition ID: 12360

About the Role:

Natus Medical is hiring for Post Market Quality Assurance Research, responsible for Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) for Natus Sensory Medical products. This role ensures regulatory compliance and supports risk management, clinical evaluation, and product development.

Key Responsibilities:

  • Ensure compliance with ISO13485, MDR 2017/745, FDA 21CFR Part 820, and other global regulatory requirements.
  • Develop, write, and edit PMS and PMCF Plans/Reports for product families.
  • Lead PMS and PMCF meetings, collecting essential documentation for compliance.
  • Conduct literature reviews on current scientific findings for risk assessment.
  • Communicate with Clinical, Sales, Marketing, Quality Assurance, and Regulatory teams.
  • Participate in regulatory audits and defend PMS documentation.
  • Conduct clinical evaluations and write reports for Hearing/Balance Medical Devices.
  • Perform literature searches using Embase, PubMed, and Google Scholar.

Who You Are:

Educational Qualification: Bachelor's degree in Health or Life Sciences
Experience: 3-4 years in Medical Device industry
Essential Skills:

  • Post Market Surveillance (PMS) report writing
  • Clinical evaluation and regulatory research
  • Knowledge of QSR, ISO13485, MDSAP, MDR, and China Regulations

Why Join Natus Medical?

  • Work in a global regulatory environment with leading medical devices.
  • Impact patient safety and medical innovation through quality assurance.
  • Competitive benefits and equal opportunity employer.

🔗 Apply Now: Natus Medical Careers