Global Postmarket Compliance Leader

Medline Industries Holdings LP; Northfield (MN); Vor Ort; USD 154.000 - 231.000; Vollzeit

Zusammenfassung

Medline Industries, LP is seeking a leader to manage the Global Process, Systems & Center of Excellence for postmarket processes across device and pharmaceutical portfolios. You will oversee governance, harmonization, and implementation of postmarket procedures, complaint handling, and regulatory reporting.

The role focuses on driving global process effectiveness, compliance standardization, and cross‑functional collaboration with Quality, Regulatory Affairs, IT and Operations.

Qualifikationen

• Bachelor's degree in engineering, quality, regulatory or related technical field required.
• 5+ years in medical device/pharma quality or postmarket surveillance.
• Experience with FDA, ISO 13485, MDSAP, EU MDR regulatory requirements.

Aufgaben

• Lead global postmarket surveillance programs including complaint handling and regulatory reporting.
• Govern and harmonize global postmarket procedures, work instructions, and data standards.
• Oversee governance of complaint/Ae IT systems and associated changes.
• Collaborate with跨-functional partners to ensure regulatory alignment and continuous improvement.
• Drive process standardization, inspection readiness, and cross‑functional integration.

Kenntnisse

Postmarket surveillance

Complaint management

Regulatory reporting

Quality systems

Global governance

Ausbildung

Bachelor's degree in engineering/quality/regulatory

Jobbeschreibung

Medline Industries, LP is seeking a leader to manage the Global Process, Systems & Center of Excellence for postmarket processes across device and pharmaceutical portfolios. You will oversee governance, harmonization, and implementation of postmarket procedures, complaint handling, and regulatory reporting.

The role focuses on driving global process effectiveness, compliance standardization, and cross‑functional collaboration with Quality, Regulatory Affairs, IT and Operations.