Senior Manager of Quality & Regulatory Affairs Manufacturing & Utilities

Summary

Dr. Comfort is seeking a Senior Manager, Quality & Regulatory Affairs to serve as the single, accountable owner of product quality across our entire supply chain from domestically produced custom shoe inserts to finished footwear sourced from Asia Pacific manufacturing partners. This role unifies Quality Management, Regulatory Affairs, and Import/Trade Compliance under one accountable leader, ensuring that every product reaching a patient meets FDA Class I medical device requirements, applicable international standards, and company quality expectations, regardless of where it was made.

This is a hands-on leadership role suited to an experienced quality and regulatory professional who is comfortable owning outcomes end-to-end building systems and vendor governance rather than simply overseeing existing ones within a lean, privately backed operating environment following a recent corporate carve out.

Key Responsibilities

Quality Ownership & Accountability

• Serve as the single point of accountability for finished-product quality across two distinct supply streams: US-based bespoke/custom shoe insert production and Asia Pacific finished footwear vendors.
• Own the Quality Management System (QMS) in accordance with 21 CFR Part 820 (QSR) and ISO 13485 as applicable to Class I devices, including document control, CAPA, nonconformance management, and management review.
• Establish and lead a supplier quality program for APAC footwear vendors, including incoming inspection protocols, quality agreements, vendor scorecards, and on-site or virtual audits.
• Oversee quality control for domestic bespoke insert production, ensuring custom, patient-specific orders meet specification, traceability, and complaint-handling requirements.
• Lead root-cause investigation and corrective/preventive action for quality escapes, driving resolution with both domestic operations teams and overseas vendor partners.
• Own the complaint handling and Medical Device Reporting (MDR) process, ensuring timely evaluation, documentation, and FDA reporting where required.

Regulatory Affairs

• Maintain FDA establishment registration and device listing for Class I products, and ensure ongoing compliance with applicable FDA regulations.
• Monitor and interpret evolving FDA, international, and industry regulatory requirements relevant to therapeutic footwear and orthotic devices, translating changes into internal policy and process updates.
• Serve as the company's primary regulatory point of contact for audits, inspections, and inquiries from FDA and other regulatory bodies.
• Support labeling, claims review, and technical file/documentation requirements for both domestic and imported product lines.
• Maintain regulatory documentation required for government and institutional channels, including VA and other federal purchasing programs.

Import & Trade Compliance

• Own end-to-end import compliance for Asia Pacific-sourced footwear, including HTS classification, country-of-origin determination, valuation, and customs documentation.
• Serve as the company liaison to customs brokers, freight forwarders, and U.S. Customs and Border Protection (CBP) on compliance matters, entry issues, and audits.
• Maintain import compliance recordkeeping and internal controls sufficient to withstand regulatory or customs audit, and manage risk related to tariffs, trade agreements, and country-specific import requirements.
• Partner with Procurement and Logistics to ensure new APAC vendors and SKUs are fully compliant prior to import, avoiding shipment holds, penalties, or delays.

Cross-Functional Leadership

• Act as the escalation point connecting Procurement, Manufacturing, Logistics, and Customer Service on any quality, regulatory, or compliance matter, ensuring one accountable owner rather than shared or ambiguous responsibility.
• Partner with the SVP, Operations & Supply Chain on vendor negotiations, new supplier onboarding, and contract terms related to quality and regulatory obligations.
• Build and mentor a small internal team and/or manage external consultants/auditors as the function scales.
• Prepare quality, regulatory, and compliance metrics and reporting for executive and ownership review.

Required Qualifications

• Bachelor's degree in a relevant scientific, engineering, quality, or regulatory discipline; advanced degree or RAC/ASQ certification (CQM, CQA) a plus.
• Meets the qualification requirements to serve as the company’s Person Responsible for Regulatory Compliance (PRRC): either a relevant diploma or degree plus at least one (1) year of experience in medical-device quality or regulatory affairs, or at least four (4) years of experience in medical-device quality or regulatory affairs.
• 5-8+ years of progressive experience in Quality and/or Regulatory Affairs within medical devices, preferably Class I; direct experience with FDA QSR (21 CFR Part 820) and ISO 13485 required.
• Demonstrated experience managing quality across a multi-sourced supply chain, including direct oversight of overseas (Asia Pacific preferred) manufacturing vendors.
• Working knowledge of U.S. import/customs compliance (HTS classification, country of origin, CBP requirements) or strong ability to learn and own this function quickly.
• Experience with custom or made-to-order product quality control is a plus, given the bespoke nature of the domestic insert business.
• Proven ability to operate as a true single point of accountability — comfortable owning outcomes across functions without waiting for consensus.
• Strong written and verbal communication skills, with experience presenting to executive leadership and interfacing directly with regulatory agencies.
• Willingness to travel domestically and internationally (APAC) as needed for vendor audits and inspections.

What Dr. Comfort Offers

• A highly visible, high-impact role reporting directly into the Operations & Supply Chain leadership team during an active period of operational transformation.
• The opportunity to build and own a unified Quality, Regulatory, and Import Compliance function from the ground up, shaping process and vendor governance rather than inheriting a fixed structure.
• On-site collaborative culture at our Mequon, WI facility.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Job Description

Dr. Comfort is seeking a Senior Manager, Quality & Regulatory Affairs to serve as the single, accountable owner of product quality across our entire supply chain from domestically produced custom shoe inserts to finished footwear sourced from Asia Pacific manufacturing partners. This role unifies Quality Management, Regulatory Affairs, and Import/Trade Compliance under one accountable leader, ensuring that every product reaching a patient meets FDA Class I medical device requirements, applicable international standards, and company quality expectations, regardless of where it was made.

This is a hands-on leadership role suited to an experienced quality and regulatory professional who is comfortable owning outcomes end-to-end building systems and vendor governance rather than simply overseeing existing ones within a lean, privately backed operating environment following a recent corporate carve out.

Key Responsibilities

Quality Ownership & Accountability

• Serve as the single point of accountability for finished-product quality across two distinct supply streams: US-based bespoke/custom shoe insert production and Asia Pacific finished footwear vendors.
• Own the Quality Management System (QMS) in accordance with 21 CFR Part 820 (QSR) and ISO 13485 as applicable to Class I devices, including document control, CAPA, nonconformance management, and management review.
• Establish and lead a supplier quality program for APAC footwear vendors, including incoming inspection protocols, quality agreements, vendor scorecards, and on-site or virtual audits.
• Oversee quality control for domestic bespoke insert production, ensuring custom, patient-specific orders meet specification, traceability, and complaint-handling requirements.
• Lead root-cause investigation and corrective/preventive action for quality escapes, driving resolution with both domestic operations teams and overseas vendor partners.
• Own the complaint handling and Medical Device Reporting (MDR) process, ensuring timely evaluation, documentation, and FDA reporting where required.

Regulatory Affairs

• Maintain FDA establishment registration and device listing for Class I products, and ensure ongoing compliance with applicable FDA regulations.
• Monitor and interpret evolving FDA, international, and industry regulatory requirements relevant to therapeutic footwear and orthotic devices, translating changes into internal policy and process updates.
• Serve as the company's primary regulatory point of contact for audits, inspections, and inquiries from FDA and other regulatory bodies.
• Support labeling, claims review, and technical file/documentation requirements for both domestic and imported product lines.
• Maintain regulatory documentation required for government and institutional channels, including VA and other federal purchasing programs.

Import & Trade Compliance

• Own end-to-end import compliance for Asia Pacific-sourced footwear, including HTS classification, country-of-origin determination, valuation, and customs documentation.
• Serve as the company liaison to customs brokers, freight forwarders, and U.S. Customs and Border Protection (CBP) on compliance matters, entry issues, and audits.
• Maintain import compliance recordkeeping and internal controls sufficient to withstand regulatory or customs audit, and manage risk related to tariffs, trade agreements, and country-specific import requirements.
• Partner with Procurement and Logistics to ensure new APAC vendors and SKUs are fully compliant prior to import, avoiding shipment holds, penalties, or delays.

Cross-Functional Leadership

• Act as the escalation point connecting Procurement, Manufacturing, Logistics, and Customer Service on any quality, regulatory, or compliance matter, ensuring one accountable owner rather than shared or ambiguous responsibility.
• Partner with the SVP, Operations & Supply Chain on vendor negotiations, new supplier onboarding, and contract terms related to quality and regulatory obligations.
• Build and mentor a small internal team and/or manage external consultants/auditors as the function scales.
• Prepare quality, regulatory, and compliance metrics and reporting for executive and ownership review.

Required Qualifications

• Bachelor's degree in a relevant scientific, engineering, quality, or regulatory discipline; advanced degree or RAC/ASQ certification (CQM, CQA) a plus.
• Meets the qualification requirements to serve as the company’s Person Responsible for Regulatory Compliance (PRRC): either a relevant diploma or degree plus at least one (1) year of experience in medical-device quality or regulatory affairs, or at least four (4) years of experience in medical-device quality or regulatory affairs.
• 5-8+ years of progressive experience in Quality and/or Regulatory Affairs within medical devices, preferably Class I; direct experience with FDA QSR (21 CFR Part 820) and ISO 13485 required.
• Demonstrated experience managing quality across a multi-sourced supply chain, including direct oversight of overseas (Asia Pacific preferred) manufacturing vendors.
• Working knowledge of U.S. import/customs compliance (HTS classification, country of origin, CBP requirements) or strong ability to learn and own this function quickly.
• Experience with custom or made-to-order product quality control is a plus, given the bespoke nature of the domestic insert business.
• Proven ability to operate as a true single point of accountability — comfortable owning outcomes across functions without waiting for consensus.
• Strong written and verbal communication skills, with experience presenting to executive leadership and interfacing directly with regulatory agencies.
• Willingness to travel domestically and internationally (APAC) as needed for vendor audits and inspections.

What Dr. Comfort Offers

• A highly visible, high-impact role reporting directly into the Operations & Supply Chain leadership team during an active period of operational transformation.
• The opportunity to build and own a unified Quality, Regulatory, and Import Compliance function from the ground up, shaping process and vendor governance rather than inheriting a fixed structure.
• On-site collaborative culture at our Mequon, WI facility.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance