Regulatory Affairs Specialist
Our 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 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