Global Regulatory Strategy Lead (Remote)

Regulatory Jobs; Illinois; Remote; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries is seeking a Principal Regulatory Affairs professional for a remote role overseeing global regulatory strategies for new and existing products. You will negotiate with regulators, lead cross-functional teams, and guide product development to ensure compliance and timely approvals.

The position requires strong experience with 510(k) submissions and CE Technical Files, plus expertise in risk management and regulatory intelligence across international markets.

Qualifications

• 5+ years of diverse regulatory experience in the medical device industry.
• Experience authoring/submitting regulatory submissions (510(k), CE Technical Files).
• Experience negotiating with regulatory authorities (FDA and notified bodies).

Responsibilities

• Determine requirements for regulatory submissions and market clearances across markets.
• Identify factors impacting new product launches and regulatory viability.
• Lead internal groups and coordinate with external partners to maintain filings.
• Direct communication with regulators to respond to questions/non-conformances.
• Oversee labeling and claims substantiation for multiple markets.

Skills

Regulatory strategy

Global regulatory experience

FDA submissions

CE technical files

Education

Bachelor's degree in life sciences or related

Job description

Medline Industries is seeking a Principal Regulatory Affairs professional for a remote role overseeing global regulatory strategies for new and existing products. You will negotiate with regulators, lead cross-functional teams, and guide product development to ensure compliance and timely approvals.

The position requires strong experience with 510(k) submissions and CE Technical Files, plus expertise in risk management and regulatory intelligence across international markets.