Regulatory Affairs Manager

Job Description

Extension is seeking a Regulatory Affairs and Quality Systems Manager for a direct-hire opportunity with one of our clients located in Pewaukee, WI

Overview

An established medical device technology organization is seeking an experienced Regulatory Affairs and Quality Systems Manager to lead its regulatory compliance and quality systems functions. This individual will oversee global regulatory requirements, maintain the QMS, and support the full product lifecycle, with a focus on Software as a Medical Device (SaMD).

Responsibilities

• Lead regulatory affairs and quality management programs
• Manage FDA, ISO 13485, EU MDR, MDSAP, and global regulatory compliance
• Oversee global product registrations, licensing, and regulatory submissions
• Maintain QMS processes, including CAPA, audits, document control, and post-market surveillance
• Lead internal, customer, and regulatory audits
• Review and approve technical documentation, labeling, and submissions
• Serve as the primary contact for regulatory agencies and notified bodies

Qualifications

• Bachelor's degree in Engineering, Science, or related field
• 5+ years of medical device regulatory affairs experience
• Direct SaMD/MDSW experience
• Hands-on EU MDR technical documentation experience
• Strong knowledge of FDA, ISO 13485, ISO 14971, MDR, and MDSAP
• Experience managing QMS, CAPA, audits, and global registrations

Salary and Schedule

• Salary: $120,000–$155,000 annually
• Location: Pewaukee, WI - onsite
• Schedule: Full-time, Monday-Friday 8am-5pm
• Reason for Opening: Upcoming retirement