Regulatory Affairs Manager responsible for U.S. pesticide product registrations and overseeing regulatory strategies for BASF's Agricultural Solutions division. Collaborating across teams to support product registrations and compliance with regulations.
About the role
- 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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