Regulatory Affairs Specialist
About this role
Regulatory Affairs Specialist
The Regulatory Affairs Specialist supports the regulatory strategy, prepares and maintains registrations and listings, and ensures ongoing compliance with global regulatory bodies. This role partners closely with Quality, Operations and Sales and Marketing to help guide customers from onboarding through commercialization.
Duties and Responsibilities
- Assist the Regulatory Affairs Manager (RAM) with the maintenance and upkeep of registration and listings for each of the sterilization sites.
- Perform activities for Food Safety Modernization Act (FSMA) as a Preventive Control Qualified Individual (PCQI) and/or Food Defense Qualified Individual (FDQI).
- Manage the FDA annual update process to ensure that all listings are received and entered
- Assist facility Customer Service with questions from customers relating to FDA registration and listings.
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