Senior Specialist, QARC
Core
Ensuring organizational compliance with quality processes, regulatory requirements, and harmonized standards for in vitro diagnostics and medical devices, including product registration and remediation of compliance gaps.
Role type
Senior Specialist, Quality Assurance and Regulatory Compliance
Builds
Diagnostic solutions for cancer diagnostics and life sciences
Domain
Life sciences, diagnostics, biotechnology, medical devices
Deliverable
client delivery
Required skills
IVD product registration, technical documentation management, license maintenance, regulatory labeling compliance, import/warehousing process compliance, action plan development
Preferred skills
Regulatory and Quality Assurance dual experience, highly regulated manufacturing environment experience
Technologies
SAP
Responsibilities
Perform IVD product registrations with local governments; maintain licenses and complete renewals; ensure labeling and UDI compliance; plan registration strategies for product launches and market expansion; ensure process compliance for product import and delivery
Seniority
Senior, hands-on IC