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, which will align successfully in the organization.

Job Title: Regulatory Affairs Specialist

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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.