Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
About the role
- Process Compliance Manager maintaining compliance processes for medical device manufacturing. Responsible for quality management system adherence and regulatory audits compliance.
Responsibilities
- Maintains an efficient quality management system in accordance to the QSMR
- Develops monthly reports (CAPA, OFI, and OB) for Leadership Team
- Serves as main audit facilitator of FDA, ISO and ACHC external audits and assessments
- Provides support to product compliance, engineering and product development personnel
- Serves as main quality management system regulation (QMSR) software contact for implementation, support, training, and improvement activities
- Maintains external contacts in areas relating to process compliance
Requirements
- Bachelor’s Degree in a Quality or Compliance related field
- At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
- Knowledge of quality management systems, manufacturing planning, inventory control, and production processes
- Knowledge of ISO13485, FDA, ACHC, and European Medical Device Regulation (EUMDR) requirements
- Knowledge of different computer software: Windows, Microsoft Word, Excel, PowerPoint, document control, and enterprise resource planning (ERP)
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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