PMS Analyst

6 hours ago


Pune, Maharashtra, India Cyient Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Roles & Responsibilities

  • Conduct post-market data analysis (complaints, adverse events, service reports, literature, vigilance data).
  • Prepare and maintain PMS reports, PSURs, and trend analyses.
  • Support risk management updates and product safety evaluations.
  • Collaborate with cross-functional teams for CAPA and field actions.
  • Ensure compliance with EU MDR, ISO 13485, and ISO 14971 requirements.
  • Support audit and regulatory submission activities.

Qualifications

  • Bachelor's degree in Engineering, Medical, Biomedical, or related field.
  • 3–5 years' experience in PMS, complaint handling, or post-market quality (medical device preferred).
  • Strong knowledge of EU MDR, ISO 13485, and vigilance reporting requirements.
  • Analytical mindset with strong data interpretation and reporting skills.
  • Excellent communication and documentation skills.


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