Remote Global Regulatory Strategy Lead

Medline Industries, LP; Illinois; Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for global product approvals and maintain existing products. The role is remote and requires independent leadership in negotiating with regulatory authorities and guiding large-scale projects with significant business impact.

Key responsibilities include leading regulatory submissions (510(k)s, CE Technical Files), monitoring changes in regulations, and directing cross-functional teams

Qualifications

• Education: B.A. or B.S. degree in life science field or related.
• Strong global background (5+ years) of diverse regulatory experience in medical devices incl. pre/post-market submissions.
• Extensive experience authoring/submitting regulatory submissions including 510(k)s and CE Technical Files.
• Experience negotiating with FDA and notified bodies.

Responsibilities

• Determine requirements for completing and maintaining product submissions for clearance/approval in assigned markets.
• Identify and provide solutions for factors impacting new product launch viability.
• Monitor regulatory changes and implement necessary changes to procedures, products, or records.
• Lead communication with regulators to respond to questions and non-conformances.
• Direct and lead regulatory filing activities with internal and external groups.

Skills

Regulatory strategy

FDA knowledge

Global regulation

510(k) submissions

Regulatory negotiations

Leadership

Education

B.S. in life sciences

Job description

Medline Industries, LP is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for global product approvals and maintain existing products. The role is remote and requires independent leadership in negotiating with regulatory authorities and guiding large-scale projects with significant business impact.

Key responsibilities include leading regulatory submissions (510(k)s, CE Technical Files), monitoring changes in regulations, and directing cross-functional teams