Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs Specialist will author, format, track, store, review and update Quality Assurance documents that ensure compliance with applicable regulations.

Essential Duties and Responsibilities:

  • Work in conjunction with other departments to prepare, review and maintain compliance documents to ensure accuracy, quality, and integrity
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, and comprehensiveness
  • Maintain files and retrieve requested documents during inspections, audits, traceability exercises, recalls, business continuity, etc
  • Provide responses to regulatory agencies regarding product information, audits, or issues
  • Evaluate applicable laws and regulations to determine impact on company activities and processes
  • Perform other duties as assigned

  

Minimum Requirements:

  • 3+ years’ experience in technical writing
  • Experience in Food Product Manufacturing a must
  • Experience with the following regulations: FDA, GMPs, HACCP
  • Strong attention to detail
  • Advanced written and verbal communication skills
  • Sound time management and prioritization skills
  • Ability to work well with various departments in the company
  • Proficient with MS Office programs

 

Work Environment and Physical Requirements:

  • Constant exposure to allergens such as milk, eggs, fish, tree nuts, peanuts, wheat and soybeans
  • Constant operation of a computer and other office machinery such as calculator, copy machine, etc
  • Must be able to remain in a stationary position over 50% of the time