Biologo/a
Core
Support quality management and certification activities for medical devices, specifically in controlled contamination environments (Clean Rooms).
Role type
Quality and Regulatory Specialist (Biologist)
Builds
Medical devices including special single-use syringes and equipment
Domain
Medical devices / Pharmaceutical industry
Deliverable
dashboards & analysis
Required skills
Knowledge of quality management systems, familiarity with ISO 13485 and FDA 21 CFR Part 820, analytical capabilities, attention to detail
Preferred skills
Prior experience in quality, certifications, or regulatory affairs within the biomedical or medical device sector
Responsibilities
Support management and maintenance of company certifications, collaborate on technical and quality documentation for medical devices, verify compliance with applicable regulatory requirements, manage Clean Room procedures and documentation
Seniority
Junior to Mid-level