Regulatory Affairs Specialist
hace 1 mes
Overview
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.
About the Role:
- Collaborate with RAQA management to drive business objectives.
- E nsure compliance with RAQA record management processes.
- Lead and manage non-conformities, follow-up plans for CAPAs.
- Document tracking and control in SAP.
- Support regulatory submissions to INVIMA and other regulatory entities.
- Prepare and update quality agreements.
- Manage internal customer document management.
- Regulatory and quality databases management.
- F ollow-up on regulatory processes with the factory.
- F ollow-up and preparation of meeting and committee minutes.
- Provide technical and sanitary product documents.
- Issue letters to customers.
Budget and Benefits:
The ideal candidate will have an estimated annual salary of $80,000 based on industry standards and location. This role also offers a range of benefits, including professional growth opportunities, and a dynamic work environment.
Skills and Qualifications:
- 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. Intermediate English language proficiency. Knowledge of ISO and/or ISO-13485.
International Mobility:
This position requires occasional international travel (up to 10% of the time).
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