Quality Assurance and Regulatory Affairs Specialist
hace 1 semana
About the Position
Job Summary
We are seeking a highly skilled Quality Assurance and Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen. The ideal candidate will have a strong background in Quality Assurance and Regulatory Affairs, with experience in the Medical Device and/or RDIV industry.
Key Responsibilities
- Support RAQA management with a business focus, ensuring compliance with regulatory requirements and industry standards.
- Lead and manage non-conformities, follow-up plans for CAPAs, and document tracking and control in SAP.
- Prepare and submit regulatory submissions to INVIMA and other regulatory entities, ensuring timely and accurate submissions.
- Develop and maintain quality agreements, and manage internal customer document management.
- Manage regulatory and quality databases, and follow-up on regulatory processes with the factory.
- Prepare and update meeting and committee minutes, and provide technical and sanitary product documents.
- Issue letters to customers, and review registration requests received in detail and provide appropriate responses and support to stakeholders.
Managed Budget (if applicable) & KPI
- Ensure timely submission of regulatory dossiers, and track regulatory plans and quality assurance planning.
- Generate improvement proposals, continuous development, and involvement in projects.
Internal Networks/Key Relationships
The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively with customers, external suppliers, marketing managers, department managers/directors, and general manager.
Skills and Abilities:
- Strong analytical and problem-solving skills, with the ability to negotiate and lead teams.
- Excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.
- Strong knowledge of regulatory requirements and industry standards, with the ability to stay up-to-date with changing regulations.
- Ability to work under pressure, with a strong attention to detail and organizational skills.
Minimum Knowledge and Experience Required for the Position:
- 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-.
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