Head of Quality & Regulatory Affairs - Medical Devices

Dr. Comfort; Milwaukee (WI); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

On-site Mequon, WI facility

Job summary

Dr. Comfort is seeking a Senior Manager, Quality & Regulatory Affairs to own product quality across the complete supply chain, unifying QMS, regulatory, and import compliance for US-based inserts and APAC footwear vendors.

The role requires leadership across QA, regulatory, and vendor governance in a lean environment, with responsibility for FDA compliance, MDR, and global standards, including travel for audits and inspections.

Qualifications

• Bachelor's degree in a relevant scientific, engineering, quality, or regulatory discipline; advanced degree or RAC/ASQ certification a plus.
• Meets qualification to serve as PRRC: degree plus 1 year medical-device regulatory/quality or 4 years experience.

Responsibilities

• Serve as the single point of accountability for finished-product quality across US bespoke inserts and APAC vendors.
• Own QMS per 21 CFR Part 820 and ISO 13485 applicable to Class I devices; manage document control, CAPA, nonconformance, and mgmt review.
• Lead supplier quality program for APAC vendors with QA agreements, scorecards, and audits.
• Oversee quality control for domestic insert production ensuring traceability and complaint handling.
• Lead root-cause investigation and CAPA for quality escapes with domestic and overseas teams.
• Own MDR process, FDA reporting when required, and regulatory compliance across product lines.
• Maintain FDA establishment registration and device listing and monitor evolving FDA/international regs.
• Own end-to-end import compliance for APAC-sourced footwear, HTS, origin, valuation, and CBP interactions.
• Partner with Procurement/Logistics to onboard compliant APAC vendors; avoid holds and penalties.
• Prepare quality/regulatory metrics for executive review.
• Travel domestically and internationally as needed for audits.

Skills

Quality management

Regulatory affairs

FDA QSR 820

ISO 13485

Vendor governance

Leadership

Cross-functional

Education

Bachelor's degree

RAC/ASQ certification

Job description

Dr. Comfort is seeking a Senior Manager, Quality & Regulatory Affairs to own product quality across the complete supply chain, unifying QMS, regulatory, and import compliance for US-based inserts and APAC footwear vendors.

The role requires leadership across QA, regulatory, and vendor governance in a lean environment, with responsibility for FDA compliance, MDR, and global standards, including travel for audits and inspections.