Regulatory Affairs Specialist

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.
• Manage the GDUFA (Generic Drug User Fee Amendment) annual requirements, including fee payments and self-identification of the relevant facilities.
• Timely response to Customer Service requests for urgent listings from customers.
• Provide training to new Customer Service representatives on the annual update process for registration and listings.
• Assist the Regulatory Affairs Manager with regulatory projects as needed.
• Monitor the FDA Registration email inbox and respond as appropriate.
• Deliver reports of specific facility information to be presented at inspections/audits.
• Work with global facilities to understand what is needed for each based on what products are being processed.
• Act as the subject matter expert for regulatory registrations and listings.
• Assist with Food Safety and Food Defense plan changes for the facilities.
• Collaborate with the Regulatory Affairs Manager on document updates needed as related to regulatory compliance.
• Performs other duties as assigned.

Supervision Given

May supervise daily workflow of Regulatory Affairs activities or other staff.

Experience And Skills Required

• Bachelors degree in Life Sciences, Engineering, or related field.
• Two years of related regulatory affairs experience in Medical Device, Pharmaceuticals, Tissue or Food.
• Working knowledge of FDA, ISO 13485, and other applicable government regulations.
• Familiarity with the FDA registration and listing systems such as FURLS and CDERDirect is preferred.
• Must be detail oriented and able to spot errors that require correction.
• PCQI/FDQI certification is preferred.
• Knowledge of FSMA and associated requirements is preferred.
• CAPA and controlled document change experience.

Special Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Training Required

Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.