Global Regulatory Strategy Lead (Medical Devices)

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

Benefits offered by this job

Total rewards package

Continuing education and training

Job summary

Medline Industries, LP seeks a Regulatory Specialist Principal to spearhead global regulatory strategies for new products and sustain existing offerings. You will negotiate with regulators, guide cross-functional teams, and drive submissions (510(k)s and CE Technical Files) to ensure multi-market compliance.

The role demands a strong global background and the ability to resolve complex regulatory challenges independently while supporting ongoing product development and strategic business

Qualifications

• Bachelor's or higher in life science, engineering, regulatory science, or related field.
• 5+ years global regulatory experience in medical devices, including pre- and post-market activities.
• Extensive experience authoring 510(k)s and CE Technical Files; strong regulator negotiations.

Responsibilities

• Determine regulatory submission requirements and strategies for national or multi-national launches.
• Communicate regulatory requirements to internal/external stakeholders and advise on pathways.
• Review documentation to meet regulatory standards across markets.
• Lead internal groups to complete regulatory filings and coordinate with regulators.
• Lead labeling and claims development for multiple markets/projects.
• Manage complex regulatory projects with clear timelines and deliverables.

Skills

Regulatory strategy

Project leadership

Regulatory intelligence

FDA communications

Education

Bachelor's degree in life sciences

Job description

Medline Industries, LP seeks a Regulatory Specialist Principal to spearhead global regulatory strategies for new products and sustain existing offerings. You will negotiate with regulators, guide cross-functional teams, and drive submissions (510(k)s and CE Technical Files) to ensure multi-market compliance.

The role demands a strong global background and the ability to resolve complex regulatory challenges independently while supporting ongoing product development and strategic business