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Job Title: Regulatory Affairs Specialist (Contract - 12 Months)

Location: Neenah, Wisconsin (Hybrid Remote/On-site)

Job Description:

• Provide regulatory support for the development and implementation of regulatory strategies to ensure compliance with US FDA and Health Canada regulations.
• Assess regulatory requirements for design controls, change management, labeling, and ad promo reviews.
• Support procedure/SOP development and continuous improvements.
• Conduct regulatory impact assessments.
• Collaborate with cross-functional teams including R&D, Legal, Quality, and Marketing.

Qualifications:

• Bachelor's degree in a life science discipline.
• 5-7 years of regulatory experience in Class I Medical Device, Consumer Products, and Cosmetic Products.
• Familiarity with US FDA Design Controls Process.

Responsibilities:

• Define regulatory requirements and deliverables for product development projects.
• Provide feedback on proposed product designs to address regulatory hurdles.
• Develop regulatory strategies and tactical plans for compliance.
• Monitor and implement regulatory requirements.
• Resolve regulatory and quality issues.
• Support product change management and ensure regulatory compliance.
• Stay informed about domestic and international regulatory developments.
• Collaborate on labeling and product claims development.
• Provide guidance on compliance with FDA and Health Canada requirements.
• Monitor regulatory changes and assess their impact on products.