Remote Global Regulatory Strategy Lead

Medline; Northern (KY); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Bonus/incentive eligible

Job summary

Medline is seeking a Principal Regulatory Affairs professional for a remote, nationwide role. The candidate will develop regulatory strategies for global approvals, negotiate with regulators, and guide product development to ensure timely market entry and ongoing compliance.

The role requires leading cross-functional teams, driving regulatory submissions (510(k) and CE Technical Files), and monitoring regulatory changes across multiple international markets.

Qualifications

• 5+ years of diverse regulatory experience in the medical device industry, including pre- and post-market activities.
• Experience authoring and submitting regulatory filings for 510(k)s and CE Technical Files.
• Experience negotiating with regulatory authorities and leading cross-functional groups.

Responsibilities

• Determine regulatory submission requirements for clearance/approval in assigned markets (global scope).
• Lead internal and external teams to obtain supporting technical information and substantiate filings.
• Communicate regulatory requirements to internal/external stakeholders and provide strategy recommendations.

Skills

Regulatory strategy

FDA submissions

Global/regulatory

CE/Notified bodies

Regulatory intelligence

Education

Bachelor’s degree

Job description

Medline is seeking a Principal Regulatory Affairs professional for a remote, nationwide role. The candidate will develop regulatory strategies for global approvals, negotiate with regulators, and guide product development to ensure timely market entry and ongoing compliance.

The role requires leading cross-functional teams, driving regulatory submissions (510(k) and CE Technical Files), and monitoring regulatory changes across multiple international markets.