Regulatory Affairs Manager – Medical Devices (Hybrid)

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

Job summary

Medline Industries, LP in Eagan, MN seeks a Manager Regulatory Affairs to lead regulatory strategy for medical device divisions within a hybrid work model. You will oversee the regulatory affairs team and coordinate domestic and international approvals.

The role requires at least 4 years in regulatory affairs for medical devices, RAC certification, and experience with 510(k) and CE files. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences or Engineering.
• At least 4 years of experience in regulatory affairs for medical devices.
• Experience writing 510(k)s and CE technical files.
• RAC certification within certification/licensure is indicated.

Responsibilities

• Guide regulatory and licensing decision-making based on medical device requirements.
• Complete and maintain regulatory filings by leading internal groups and collaborating with external groups.
• Oversee communication of regulatory requirements to internal or external customers and regulators.
• Develop and implement processes to maintain regulatory compliance for pre- and post-market activities.

Skills

Regulatory affairs

Medical device regulations

Project management

Word and Excel

Education

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

Tools

SAP

Job description

Medline Industries, LP in Eagan, MN seeks a Manager Regulatory Affairs to lead regulatory strategy for medical device divisions within a hybrid work model. You will oversee the regulatory affairs team and coordinate domestic and international approvals.

The role requires at least 4 years in regulatory affairs for medical devices, RAC certification, and experience with 510(k) and CE files. Travel up to 15% may be required.