PMS Analyst
2 weeks ago
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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