Manager - Quality & Regulatory Affairs
Core
Develop and lead global regulatory strategies to secure and maintain approvals for Versah's medical device portfolio, ensuring audit-ready compliance and enabling global market access.
Role type
Manager, Medical Device Regulatory Affairs & Quality Systems
Builds
Medical device products (dental osteotomy and bone densification technologies) for global markets
Domain
Medical Devices / Dental Implants / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, medical device regulations (21 CFR 820, QMSR, ISO 13485, MDD, EU MDR), quality systems management, regulatory filings, health authority interaction, cross-functional leadership, supplier qualification, UDI compliance, import/export compliance
Preferred skills
RAPS certification, formal regulatory training
Technologies
21 CFR 820, QMSR, ISO 13485, MDD, EU MDR
Responsibilities
Develop and lead global regulatory strategies; interpret regulations into business requirements; prepare and submit international regulatory filings; provide regulatory guidance to cross-functional partners; drive maintenance of the Quality Management System; support external audits and inspections; manage UDI compliance and import/export regulations
Seniority
Manager, strategic ownership & cross-functional leadership