Regulatory Compliance Specialist
2 weeks ago
Position Title: Senior Regulatory Affairs Consultant
Overview:
The Senior Regulatory Affairs Consultant plays a crucial role in assessing and ensuring the precision of labeling for in vitro diagnostic products. This position provides an exceptional opportunity to engage with diverse teams, including Technical Publications, Product Transfer, Quality Assurance, Research & Development, and Clinical Affairs, as part of the global change management process. The consultant is responsible for maintaining regulatory compliance of product labeling while gaining exposure to a wide range of innovative diagnostic products and technologies.
Key Responsibilities:
- Process Familiarization: Acquire a comprehensive understanding of the global change management protocols.
- Review and Execution: Analyze change proposals and execute modifications to product labeling and instructions for use.
- Collaborative Engagement: Work alongside various stakeholders to guarantee the accuracy of labeling updates.
- Regulatory Adherence: Collaborate with the Technical Publications team to ensure the publication of regulatory-compliant labeling for products.
Qualifications:
- Bachelor's degree with a minimum of 5 years of relevant experience, or a Master's degree with at least 3 years of experience, or a Doctoral degree with 0-2 years of experience.
- Comprehensive knowledge of regulatory affairs principles and familiarity with guidelines for the development and labeling of diagnostic products.
- Understanding of Quality Management System regulations and standards.
- Proficiency in Microsoft Office Suite and Adobe Acrobat.
Preferred Qualifications:
- Experience in managing labeling controls and change processes.
- Familiarity with the Corrective and Preventative Action (CAPA) framework.
- Experience with Agile documentation systems.
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