Regulatory Affairs Specialist

Regulatory Affairs SpecialistOur client, a leader in the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs Department supporting global post-market compliance activities. The ideal candidate will have attention to detail, strong analytical skills, and excellent collaboration abilities.Location: Maple Grove, MN (Hybrid, 3 days onsite weekly)What's the Job?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.What's Needed?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.What's in it for me?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.Upon completion of waiting period consultants are eligible for:Medical and Prescription Drug PlansDental PlanVision PlanHealth Savings AccountHealth Flexible Spending AccountDependent Care Flexible Spending AccountSupplemental Life InsuranceShort Term and Long Term Disability InsuranceBusiness Travel Insurance401(k), Plus MatchWeekly Pay