Work from Office
Full Time
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.
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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