Regulatory Affairs Senior Specialist
2 weeks ago
Overview:
The Regulatory Affairs Senior Specialist plays a crucial role in the evaluation and assurance of labeling precision for in vitro diagnostic products. This position provides an exceptional opportunity to engage with various teams, including Technical Publications, Product Transfer, Quality Assurance, Research & Development, and Clinical Affairs, as part of the global change management process. The role is pivotal in ensuring that product labeling adheres to regulatory standards while offering exposure to a variety of diagnostic products and innovative technologies.
Key Responsibilities:
- Process Familiarization: Gain a comprehensive understanding of the global change management procedures.
- Review and Execution: Assess change proposals and execute modifications to product labeling and instructions for use.
- Collaborative Engagement: Work closely with stakeholders to guarantee the accuracy of labeling updates.
- Regulatory Adherence: Collaborate with the Technical Publications team to produce labeling that meets regulatory compliance for products.
- Bachelor's degree with a minimum of 5 years of relevant experience, or a Master's degree with at least 3 years of relevant experience, or a Doctoral degree with 0-2 years of relevant experience.
- Thorough understanding of regulatory affairs principles and familiarity with guidelines for the development and labeling of diagnostic products.
- Knowledge of Quality Management System regulations and standards, particularly those governing change management and Corrective and Preventative Actions (CAPA).
- Proficiency in Microsoft Office Suite and Adobe Acrobat.
- Experience in managing labeling controls and change processes.
- Familiarity with the CAPA process.
- Experience with Agile documentation systems.
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