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Regulatory Affairs Expert
2 months ago
Overview:
The Regulatory Affairs Senior Specialist at MyKelly is tasked with assessing and ensuring the precision of labeling for in vitro diagnostic products. This role presents a distinctive opportunity to engage with cross-functional teams, including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs, as part of the global change control process. The position guarantees adherence to regulatory standards for product labeling and provides exposure to a variety of in vitro diagnostic products, cutting-edge technologies, and methodologies that foster continuous improvement and facilitate the introduction of new products to the market.
Location: Remote (Hybrid)
Shift: Standard working hours, Monday to Friday
Contract Duration: Temporary position
Compensation: Competitive hourly rate
Key Responsibilities:
- Process Familiarization: Gain a comprehensive understanding of the global change control procedures.
- Review and Execution: Evaluate change plans and implement modifications to product labeling and instructions for use.
- Collaborative Engagement: Collaborate with stakeholders to ensure the accuracy of labeling modifications.
- Regulatory Adherence: Work alongside the Technical Publications team to produce regulatory-compliant labeling for MyKelly 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.
- Comprehensive knowledge of regulatory affairs principles and familiarity with regulations and guidelines pertaining to diagnostic product development and labeling claims.
- Understanding of Quality Management System (QMS) regulations and standards.
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
- Experience in labeling control and change management.
- Familiarity with the Corrective and Preventative Action (CAPA) process.
- Experience with Agile documentation systems.
