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Regulatory Affairs Manager

2 months ago

Eden Prairie, Minnesota, United States ShopHQ Full time
Job Title: Product Integrity Specialist

**Job Summary:**

We are seeking a highly skilled Product Integrity Specialist to join our team at ShopHQ. As a key member of our compliance team, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Product Compliance:
    • Interpret and apply policies, procedures, and regulations related to product safety and compliance.
    • Assess conformity to FDA and FTC requirements for cosmetics, OTC drugs, medical devices, dietary supplements, and food products.
    • Review performance of third-party testing and laboratory analysis, including claims substantiation, efficacy testing, safety testing, and cGMP compliance.
    • Collaborate with cross-functional teams to ensure all required product-specific assets are reviewed and set up accurately.
  • Standards & Practices:
    • Interpret and apply policies, procedures, and regulations related to product safety and compliance.
    • Perform regular proactive QA audits of products and report results.
    • Draft written and verbal QA policy/process communications for business teams.
    • Manage issues regarding product claims and their substantiation and troubleshoot other advertising issues.
    • Assist General Counsel and Outside Counsel on product and advertisement compliance concerns.
    • Collaborate with General Counsel to identify potential issues and develop proactive solutions to eliminate or mitigate risks.
  • Cross-functional Team Support:
    • Support vendor onboarding documents in collaboration with Legal and Merchandising.
    • Provide regulatory guidance and answer compliance-related questions to cross-functional teams.
    • Provide compliance support for state cause marketing, and FTC/state sweepstakes, contest, and price promotions and other social promotion compliance.
    • Assist Item Management Specialists with web description reviews for Extended Assortment.
  • Value-added Activities:
    • Perform administrative tasks for Legal Compliance, including filing documentations and record keeping.
    • Educate cross-functional teams on the Standards of Operating Procedures.
    • Continuous professional development to provide thorough compliance-related guidance.

Qualifications/Knowledge, Skills & Abilities:

  • Bachelor's degree or equivalent experience in a related subject matter area.
  • 3-5 years of relevant work experience preferred.
  • 1-2 years of supervisory experience preferred.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Effective written and verbal communication skills.
  • Ability to understand technical scientific studies and laboratory analyses.
  • Working knowledge of FTC and FDA laws and regulations as well as all known Federal, state, and local regulations for assigned categories.
  • Ability to manage processes.
  • Self-motivated, timely, reliable, and responsive to time-urgent matters.
  • Decision-making, organization, and planning skills.
  • Working knowledge of Microsoft Office Suite.