Global Regulatory Affairs Leader, Medical Devices

AMETEK; Mount Prospect (IL); On-site; USD 175,000 - 200,000; Full time

Job summary

Rauland, a division of AMETEK, seeks a Sr. Manager, Regulatory Affairs to lead the global regulatory function and ensure compliance with FDA, EU MDR, and other international requirements. You will shape regulatory strategy across product development, market access, and lifecycle management.

You will oversee submissions and registrations, advise cross‑functional teams, drive post‑market activities, audits, and continuous improvement, while building a high‑performing regulatory organization.

Qualifications

• Bachelor's degree in engineering, life sciences, regulatory affairs, or related field.
• Minimum 10 years progressive regulatory affairs experience in medical devices.
• Minimum 5 years of leadership and people management.
• Experience leading FDA 510(k) submissions for Class I/II devices.
• Experience implementing EU MDR requirements and global registrations.
• Experience with SaMD, cybersecurity, and software regulatory frameworks.
• Experience with eQMS systems (e.g., MasterControl, QT9).
• RAC or related certifications preferred.

Responsibilities

• Develop and execute global regulatory strategies for product lifecycle and market access.
• Lead FDA 510(k) submissions and international regulatory filings.
• Ensure compliance with FDA QMSR, EU MDR, MDRs, UDI/GUDID, CE labeling, and post‑market requirements.
• Collaborate with Engineering, Product, Clinical, Quality, and Operations to embed regulatory requirements.
• Oversee post-market surveillance, adverse event reporting, and regulatory reporting.
• Establish regulatory intelligence program to monitor trends and enforcement.
• Lead internal and external audits and regulatory inspections.
• Develop training on regulatory requirements and quality systems.
• Support field actions, recalls, and regulatory investigations as needed.
• Drive continuous improvement and regulatory excellence across the organization.

Skills

Leadership

Regulatory affairs

Cross-functional collaboration

Strategic thinking

Regulatory submissions

Regulatory intelligence

Problem solving

Stakeholder influencing

Travel readiness

Education

Bachelor's degree in Engineering/Regulatory Affairs/Life Sciences/Quality

Advanced degree preferred

Tools

MasterControl

QT9

Job description

Rauland, a division of AMETEK, seeks a Sr. Manager, Regulatory Affairs to lead the global regulatory function and ensure compliance with FDA, EU MDR, and other international requirements. You will shape regulatory strategy across product development, market access, and lifecycle management.

You will oversee submissions and registrations, advise cross‑functional teams, drive post‑market activities, audits, and continuous improvement, while building a high‑performing regulatory organization.