Hybrid Regulatory Affairs Manager – Medical Devices

Medline; 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 in Eagan, MN is seeking a Manager Regulatory Affairs to lead regulatory programs for medical devices. The role supports domestic and international approvals and guides a team in a hybrid work setting.

The ideal candidate has 4+ years in regulatory affairs, deep device regulation knowledge, and strong communication with regulators and executives. Travel up to 15% is expected.

Qualifications

• At least 4 years of experience in regulatory affairs for medical devices.
• Ability to manage multiple projects in a fast-paced environment.
• Strong understanding of medical device regulations for pre- and post-market activities.
• Ability to present to senior management and non-technical audiences.
• Willingness to travel up to 15%.

Responsibilities

• Guide regulatory and licensing decision-making per device regulations.
• Lead regulatory filings and coordinate with internal and external groups.
• Communicate regulatory requirements to stakeholders and regulators.
• Develop and implement processes for regulatory compliance across R&D and quality.
• Monitor regulatory changes and advise on strategies and actions.
• Oversee staff performance, hiring, and development.

Skills

Project management

Microsoft Word

Microsoft Excel

Regulatory knowledge

Stakeholder communication

Travel readiness

Education

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

Tools

SAP

Job description

Medline Industries in Eagan, MN is seeking a Manager Regulatory Affairs to lead regulatory programs for medical devices. The role supports domestic and international approvals and guides a team in a hybrid work setting.

The ideal candidate has 4+ years in regulatory affairs, deep device regulation knowledge, and strong communication with regulators and executives. Travel up to 15% is expected.