Regulatory Affairs Manager, Medical Devices (Hybrid)

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Eagan, MI is seeking a Manager Regulatory Affairs to oversee regulatory programs for medical device divisions in a hybrid work model.

This role includes guiding regulatory decisions, leading filings, and coordinating with regulators to ensure compliance across pre- and post-market activities. Bachelor’s degree and 4+ years in regulatory affairs are required. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences or Engineering.
• At least 4 years of regulatory affairs experience for medical devices.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Guide regulatory and licensing decisions based on medical device requirements.
• Lead regulatory filings by coordinating internal and external teams.
• Communicate regulatory requirements to stakeholders.
• Engage with regulators to address non-conformances and questions.
• Develop processes to maintain pre- and post-market regulatory compliance.
• Monitor changes in regulatory environments and advise accordingly.
• Assess records against multiple regulatory sources and standards.

Education

Bachelor’s Degree in Regulatory Affairs/Life Sciences/Engineering

Multi-project management

Regulatory affairs (medical devices)

Tools

Microsoft Word

Microsoft Excel

Job description

Medline Industries, LP in Eagan, MI is seeking a Manager Regulatory Affairs to oversee regulatory programs for medical device divisions in a hybrid work model.

This role includes guiding regulatory decisions, leading filings, and coordinating with regulators to ensure compliance across pre- and post-market activities. Bachelor’s degree and 4+ years in regulatory affairs are required. Travel up to 15% may be required.