Regulatory Affairs Specialist

Location: Maple Grove, MN (Hybrid, 3 days onsite weekly)

About the role

Lead regulatory activities supporting product corrections, recalls, and field actions. Partner with internal global regulatory teams and external authorities regarding recall-related communications and submissions. Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting. Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes. Support internal and external audits, inspections, and compliance assessments.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline
• 12+ years of relevant industry experience
• Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry
• Minimum 2 years of direct Regulatory Affairs experience
• Strong knowledge of U.S. FDA regulations and international medical device regulatory requirements

Benefits

Upon completion of waiting period, consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

What we offer

• Opportunity to work in a dynamic and impactful healthcare environment
• Engage in meaningful projects that contribute to global health and safety
• Collaborate with a diverse and talented team of professionals
• Develop your expertise in regulatory compliance and medical device regulations
• Be part of a company committed to continuous improvement and innovation