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Regulatory Support Specialist - Food Safety - Fort Worth, TX

 


Category : Biotech/R&D/Science

Location/City : TX - Fort Worth

Id : 1590


Pace Division: LabOps

Summary:

Candidate will provide hands-on regulatory leadership for Food Safety Solutions(FSS) marketing and supply chain teams.  This individual must be able to work both independently and collaboratively through all levels of both the FSS organization and the corporate Regulatory and QA teams.  The Regulatory Support Specialist (RSS) will help ensure regulatory compliance by enhancing overall regulatory knowledge, providing actionable regulatory guidance, and driving / coordinating regulatory compliance projects.

Responsibilities:

  • Research and define regulatory requirements applicable to a service-based B2B first aid program operating within North America (US and Canada)
  • Support the FSS Creative team to define product packaging by documenting product labeling requirements as relates to OEM, branding, use & warning, and other data
  • Support the Supply chain team to implement any facility process changes necessary to comply with applicable regulatory requirements including but not limited to:  Control of non-conforming product, CA/PA, labeling and packaging control, records retention, traceability and recall capability

Requirements:

  • Bachelorís degree in Science, Business or other related field
  • Minimum of 5 years regulatory experience involving both regulated drugs and medical devices
  • Excellent verbal and written communication skills

Preferred qualifications:

  • Detailed regulatory knowledge and experience with First aid kits, products, and ancillary items in a B2B environment
  • Regulatory experience with product / packaging labeling requirements for first aid products
  • Detailed knowledge and experience defining and implementing regulatory / quality processes for supply chains including storage, re-packaging, kitting, and distribution of first aid products
  • Experience defining and writing regulatory and quality processes at the business unit / plant level

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