Regulatory Affairs Specialist
hace 4 días
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen.
Key Responsibilities
- Ensure compliance with regulatory and quality record management processes.
- Lead and manage non-conformities, follow-up plans for CAPAs.
- Document tracking and control in SAP.
- Regulatory submissions to INVIMA and other regulatory entities.
- Preparation and updating of quality agreements.
- Internal customer document management.
- Management of regulatory and quality databases.
- Follow-up on regulatory processes with the factory.
- Follow-up and preparation of meeting and committee minutes.
- Provide technical and sanitary product documents.
- Issue letters to customers.
Requirements
- Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
- Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
- Computer skills, including Word, Excel, and PowerPoint.
- Intermediate English.
- Knowledge of ISO and/or ISO -.
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