Regulatory Compliance Specialist

3 weeks ago


Loveland, Colorado, United States Antech Diagnostics Full time
Job Purpose

The Regulatory Manager plays a pivotal role in ensuring that our products and processes meet regulatory standards.

Key Responsibilities
  • Develop and implement regulatory procedures to ensure compliance with USDA regulations, as well as national and international hardware, electrical, and software product standards.
  • Maintain updated knowledge of regulatory changes affecting the company and analyzing their impact on products and processes.
  • Liaise with USDA representatives, certification bodies, and other regulatory authorities, maintaining positive and constructive relationships.
  • Coordinate the preparation and submission of all necessary regulatory documentation and reports related to USDA and other regulations.
  • Conduct internal audits and compliance assessments to ensure ongoing adherence to regulatory requirements.
  • Work closely with product development teams to advise on regulatory considerations during the design and development phases of new product development.
  • Provide regulatory guidance and training to staff, enhancing company-wide understanding of USDA and other regulatory landscapes.
  • Manage and respond to regulatory inquiries, audits, and inspections related to USDA and hardware standards.
Requirements
  • Bachelor's degree in engineering, science, or other related technical field.
  • At least 10 years of regulatory experience, with a focus on USDA or similar regulations, and a portion of which has been in a leadership role.
Working Conditions

The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak to use the telephone, make presentations, and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 15 pounds.

The associate will primarily work in a typical office environment including the use of cubicles, computers, and overhead lighting. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.

The associate may be required to work in a manufacturing space where personal protective equipment (i.e., bouffant cap, safety glasses, shoe covers, etc.) are required.



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