Global Regulatory Affairs Lead, Medical Devices (Remote)

Medline; Illinois; Remote; 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, LP has an immediate opening for a Principal Regulatory Affairs. This remote role develops regulatory strategies for global approvals and maintains existing products. You will negotiate with regulators and lead large-scale projects to inform product development.

Strong background in medical devices with 5+ years of regulatory experience, including 510(k) and CE filings, and the ability to guide cross-functional teams on regulatory intelligence and risk management.

Qualifications

• Strong global background (5+ years) in diverse regulatory work for medical devices.
• Experience authoring and submitting 510(k)s and CE Technical Files.
• Proven ability to lead negotiations with FDA and notified bodies.

Responsibilities

• Determine regulatory requirements for submissions and filings in multiple markets.
• Communicate regulatory pathways and future actions to internal teams.
• Lead internal groups to complete regulatory filings and respond to regulators.
• Direct labeling and claims development for various markets.
• Oversee audits and implement post-audit corrective actions.

Skills

Regulatory strategy

FDA submissions

CE Technical Files

Regulatory negotiations

Regulatory intelligence

Risk management

Global regulatory experience

Education

B.A. or B.S. in life sciences

Job description

Medline Industries, LP has an immediate opening for a Principal Regulatory Affairs. This remote role develops regulatory strategies for global approvals and maintains existing products. You will negotiate with regulators and lead large-scale projects to inform product development.

Strong background in medical devices with 5+ years of regulatory experience, including 510(k) and CE filings, and the ability to guide cross-functional teams on regulatory intelligence and risk management.