Regulatory Affairs Manager, Medical Devices (Hybrid)

Medline Industries, Inc.; Eagan (MN); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP, is seeking a Manager Regulatory Affairs in the Eagan, MI area with a hybrid work model. The role oversees regulatory affairs for Medline product divisions and leads the team to develop regulatory strategies for domestic and international approvals of medical devices.

The position emphasizes leadership, strategic planning, and collaboration with R&D, quality, and regulatory groups, with travel up to 15%. Competitive salary and benefits are offered.

Qualifications

• Bachelor’s Degree in Regulatory Affairs, Life Sciences or Engineering.
• At least 4 years of experience in regulatory affairs for medical devices.
• RAC certification is preferred.

Responsibilities

• Guide regulatory and licensing decisions based on regulatory requirements for medical devices.
• Lead filing efforts, coordinating internal and external groups to obtain supporting information.
• Communicate regulatory requirements to customers and regulators; respond to inquiries.
• Develop processes to maintain regulatory compliance for pre- and post-market activities.
• Monitor regulatory changes and advise on pathways, strategies, and actions.
• Oversee and develop Regulatory Affairs professionals; manage teams.

Skills

multitasking

project management

Regulatory affairs

communication

regulatory strategy

presentation

Education

Bachelor’s Degree in Regulatory Affairs, Life Sciences or Engineering

Tools

SAP

Job description

Medline Industries, LP, is seeking a Manager Regulatory Affairs in the Eagan, MI area with a hybrid work model. The role oversees regulatory affairs for Medline product divisions and leads the team to develop regulatory strategies for domestic and international approvals of medical devices.

The position emphasizes leadership, strategic planning, and collaboration with R&D, quality, and regulatory groups, with travel up to 15%. Competitive salary and benefits are offered.