Regulatory Affairs Manager - Medical Devices

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

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries seeks a Manager Regulatory Affairs at our Eagan, MN hybrid site to oversee regulatory activities for medical device divisions. You will lead cross-functional teams, coordinate regulatory submissions, and ensure compliance across pre- and post-market activities.

The role requires a Bachelor’s in Regulatory Affairs, Life Sciences, or Engineering with 4+ years of medical device regulatory experience, plus strong communication with regulators and stakeholders.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, or Engineering.
• 4+ years in regulatory affairs for medical devices.
• Ability to manage multiple projects in a fast-paced environment.
• Knowledge of pre- and post-market regulatory requirements for medical devices.

Responsibilities

• Guide regulatory and licensing decisions based on medical device requirements.
• Lead regulatory filings with internal and external groups and provide direction on supporting information.
• Communicate regulatory requirements to internal/external customers and stakeholders.
• Interact with regulators to respond to non-conformances, deficiencies, and questions.
• Develop and implement processes to maintain regulatory compliance for pre- and post-market activities.
• Monitor changes in regulatory environments and advise on pathways and actions.

Skills

Regulatory strategy

Project management

Communication with regulators

Advanced Word & Excel

Stakeholder management

Education

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

Tools

SAP

Job description

Medline Industries seeks a Manager Regulatory Affairs at our Eagan, MN hybrid site to oversee regulatory activities for medical device divisions. You will lead cross-functional teams, coordinate regulatory submissions, and ensure compliance across pre- and post-market activities.

The role requires a Bachelor’s in Regulatory Affairs, Life Sciences, or Engineering with 4+ years of medical device regulatory experience, plus strong communication with regulators and stakeholders.