Kirsten S.
Qara Compliance Analyst (Eudamed) @Stryker
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WORK HISTORY
Qara Compliance Analyst (Eudamed) @Stryker
EUDAMED, UDI, BUDI, GDMN, EMDN (European Medical Device Nomenclature)- Actor registration- UDI/Devices - Notified Bodies and Certificates- Market Surveillance Analyzing data related to Class emergency medical devices (AEDs) including product identifiers, names and classification codes, ensuring compliance with EU Medical Device Regulations. Verifying lifecycle of product and associated information, and entering into internal and EUDAMED systems. Communicating with date holders and notified bodies.
EDUCATION
UC Santa Barbara
Bachelor of Arts (B.A.), Environmental Studies
SKILLS
ABOUT KIRSTEN S.
Experienced Regulatory and Quality professional with over 7 years of expertise in regulatory compliance, document & design control, and quality assurance within the medical device, laboratory and chemical industries. Proven success in global regulatory surveillance, ensuring adherence to EU MDR and FDA standards, and facilitating seamless international market registrations. Adept at managing cross-functional collaboration, driving compliance, and achieving measurable results in high-stakes environments.• Regulatory Compliance (FDA, EU MDR, ISO 13485:2016, MDSAP, etc.)• Design Control & Documentation• Quality Assurance & CAPA Processes• Postmarket Surveillance & Adverse Event Reporting• Project & Program Management• New Product Development & Market Launches• Privacy Compliance (HIPAA, GDPR)• Good Manufacturing Practices (GMP, GDP, GLP)
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