Global Regulatory Affairs Leader

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

Job summary

AMETEK, Inc. – Rauland division in Mount Prospect, IL seeks a Sr. Manager of Regulatory Affairs to lead global regulatory strategy and ensure compliance across FDA, EU MDR, and international requirements.

Responsibilities include submissions, post-market activities, and cross-functional collaboration with Engineering, Quality, and Operations. The role demands 10+ years in medical device regulatory affairs, strong leadership, and travel up to 50%.

Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Quality, or related technical discipline required.
• Advanced degree preferred.
• Minimum 10 years of progressive Regulatory Affairs experience within the medical device industry.
• Minimum 5 years of leadership and people management experience.
• Demonstrated success leading FDA 510(k) submissions for Class I and II devices.
• Experience implementing EU MDR requirements and supporting global regulatory compliance.

Responsibilities

• Develop and execute global regulatory strategies to support product introductions, modifications, and lifecycle management.
• Manage global regulatory submissions, registrations, renewals, and certifications across authorities.
• Lead FDA 510(k) submissions and other filings for Class I and II devices.
• Ensure compliance with FDA QMSR, EU MDR, MDR, UDI/GUDID, labeling, and cybersecurity requirements.
• Collaborate with Engineering, Product Management, Clinical, Quality, and Operations to integrate regulatory requirements in Design Controls.
• Oversee post-market surveillance, complaints, vigilance, and regulatory reporting.

Education

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

Advanced degree preferred

Job description

AMETEK, Inc. – Rauland division in Mount Prospect, IL seeks a Sr. Manager of Regulatory Affairs to lead global regulatory strategy and ensure compliance across FDA, EU MDR, and international requirements.

Responsibilities include submissions, post-market activities, and cross-functional collaboration with Engineering, Quality, and Operations. The role demands 10+ years in medical device regulatory affairs, strong leadership, and travel up to 50%.