Remote Global Regulatory Affairs Principal

Regulatory Jobs; Illinois; À distance; USD 116 000 - 174 000; Plein temps

Résumé du poste

Medline Industries, LP is seeking a Principal Regulatory Affairs for a remote role. You will develop regulatory strategies for global approvals, guide product development to ensure compliance, and negotiate with regulatory authorities to support market entry and ongoing lifecycle management.

The role leads cross-functional teams, coordinates submissions (510(k) and CE), and manages labeling and regulatory records across markets.

Qualifications

• Strong global background (5+ years) in regulatory affairs for medical devices.
• Experience submitting 510(k)s and CE Technical Files.
• Experience negotiating with FDA and notified bodies.

Responsabilités

• Define and implement regulatory strategies for global product approvals.
• Lead regulatory filings and submissions for multiple markets.
• Interact with regulators to respond to questions and non-conformances.
• Coordinate labeling and claims development for markets.

Connaissances

Regulatory affairs

Regulatory strategy

Negotiation with regulators

Global regulatory

Formation

BA/BS in life science or related

Description du poste

Medline Industries, LP is seeking a Principal Regulatory Affairs for a remote role. You will develop regulatory strategies for global approvals, guide product development to ensure compliance, and negotiate with regulatory authorities to support market entry and ongoing lifecycle management.

The role leads cross-functional teams, coordinates submissions (510(k) and CE), and manages labeling and regulatory records across markets.