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Hire Michal H.

Austria

Regulatory Affairs, EMEA - MDD/MDR, IVDD/IVDR; Quality Assurance - Manufacturer/Distributor, Lead Auditor ISO9001:2015

Profile Summary

Regulatory notifications under IVDD - Czech republic, Slovakia Regulatory notifications under MDD - Central Eastern Europe Regulatory registrations under MDD - EMEA ISO 9001:2015 - leading auditor certificate, lead more than 15 audits in past year QA - Audits, CAPA - coordinator for supplier CAPA in EE, Quality Management System Review leader Adverse Events reporting coordinator, Field Safety Corrective Actions coordinator

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ☆ Biology/Life Sciences
• ☆ Biochemistry
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Hematology
• ☆ Clinical Biochemistry
• ☆ Blood Banking & Transfusion Medicine

Services

• Writing
• Research

Writing Technical Writing

Research Systematic Literature Review, Secondary Data Collection

Work Experience

Regulatory Affairs, EMEA

Smiths Medical Czech republic

November 2020 - Present

Education

Masters (Science)

Universtiy of Chemistry and Technology

September 2014 - June 2017

Certifications

• ISO 9001:2015

  Bureau Veritas

  December 2018 - Present