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Synthesis Health

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Manager, Post Market Quality & Compliance

United States $100K - $120K per year 5-10 yrs exp Legal

Lead and continuously improve post-market quality processes for SaMD products, including complaint investigations, adverse event assessments, trend monitoring, CAPAs, and field actions. Partner with cross-functional teams to address product quality and safety issues, maintain regulatory compliance, support audits, and report significant risks and trends to leadership.