Regulatory Affairs Specialist managing regulatory documentation for a European pharmaceutical company. Ensuring compliance with health authorities and supporting product lifecycle management in a hybrid model.
About the role
- Senior Quality Compliance Manager leading governance and improvement of Quality Management System at Medline. Overseeing QMS activities and ensuring regulatory compliance throughout product lifecycle.
Responsibilities
- Provides senior‑level Quality leadership focused on the governance, execution, and continuous improvement of the Quality Management System (QMS)
- Owns divisional QMS activities supporting post‑market surveillance, complaint handling and investigations, CAPA and SCAR management, supplier quality monitoring, risk management
- Leads QMS execution across data monitoring, trending, and management review inputs
- Drives corrective actions and systemic improvements through structured analysis of post‑market and supplier quality data
- Establishes and maintains inspection‑ready QMS processes, procedures, and records
- Sets operational priorities and oversees resource allocation for QMS activities
- Partners cross‑functionally to ensure sustained compliance and effective system performance
Requirements
- Bachelor’s degree in Engineering, Science, or Technical Field
- At least 5 years of experience related to the design/operation of medical device or drug combination product platforms
- At least 2 years of management experience
- Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR)
- Proficiency in analyzing and reporting data and performing statistical analysis
- Advanced skill level in Microsoft Excel
- Position requires travel up to 30% of the time for business purposes
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
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