Quality Assurance and Regulatory Affairs Specialist
hace 1 semana
Werfen is seeking a highly skilled QA RA Specialist to support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.
About the PositionThe ideal candidate will have a strong background in Quality Assurance and Regulatory Affairs, with a minimum of 2 years of experience in the Medical Device and/or RDIV industry. The successful candidate will be responsible for ensuring compliance with RAQA record management processes, leading and managing non-conformities, and preparing and updating quality agreements.
Key Responsibilities- Support RAQA management with a business focus.
- Ensure compliance with RAQA 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.
- Review registration requests received in detail and provide appropriate responses and support to stakeholders.
- Education: Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
- Experience: Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
- Additional skills/knowledge: Computer skills, including Word, Excel, and PowerPoint. Language: Intermediate English. Knowledge of ISO and/or ISO-.
Required: 10%
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