Provide Quality Assurance & Regulatory Affairs expertise to ensure product compliance, maintain quality systems, and support lifecycle activities in line with cGxP and regulatory requirements.
Key Responsibilities
Act as SME for QA/RA topics and regulatory compliance
Ensure compliance with applicable standards (GxP, ISO, FDA, EU regulations)
Support product registration, submissions, and regulatory lifecycle management
Manage deviations, CAPAs, change controls, and risk assessments
Participate in audits and inspections (internal/external)
Maintain and improve Quality Management System (QMS)
Review and approve technical and quality documentation
Profile
Engineering or scientific degree (biotech, pharmacy, chemistry or equivalent)
3+ years in QA/RA within Pharma or Medical Devices
Experience with regulatory submissions and quality systems
Skills
Knowledge of cGxP, ISO 13485, FDA, EU MDR/IVDR
French & English required (German a plus)
Strong analytical and problem-solving skills
Detail-oriented, organized, and team player
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