
Regulatory Affairs Staff
2 weeks ago
Overview
Regulatory Affairs Staff / CEZ, Rosario, Cavite
Join to apply for the Regulatory Affairs Staff / CEZ, Rosario, Cavite role at SAGASS CONSULTING
Qualifications- Licensed Pharmacist (with or without work experience).
- Regulatory Knowledge: Understanding of ISO standards (ISO 13485) and FDA regulations (preferred for applicants with prior RA experience).
- Documentation and Compliance: Strong skills in technical writing and document management.
- Data Analysis and Reporting: Proficiency in Microsoft Excel, including advanced functions.
- Risk Management: Familiarity with risk assessment methodologies (e.g., FMEA), particularly for applicants with RA experience.
- QMS Knowledge: Experience with Quality Management Systems (preferred).
- CAPA/NCR Handling: Ability to manage Corrective and Preventive Actions (CAPA) and Non-Conformance Reports (NCR), especially for applicants with RA experience.
- Entry level
- Full-time
- Legal
- Business Consulting and Services
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