[Hiring] Director of Regulatory Affairs and Quality Assurance @Braden Health LLC

Role Description

Braden Health is seeking an experienced Director of Regulatory Affairs & Quality Assurance to lead regulatory compliance and quality assurance initiatives for our growing medical-device business. This position will oversee regulatory strategy, FDA compliance, and the development and maintenance of quality management systems to support medical-device manufacturing and operations.

The ideal candidate will have demonstrated, hands-on experience in medical-device regulatory affairs and manufacturing quality, including direct authorship and management of FDA 510(k) submissions. This role requires the ability to independently manage regulatory submissions, respond to agency inquiries, conduct regulatory assessments, and establish and maintain quality systems in accordance with applicable FDA regulations and industry standards.

This is primarily a remote position with periodic travel to company locations to support operational oversight, quality assurance activities, audits, and regulatory compliance initiatives.

Qualifications

• Demonstrated experience in medical-device regulatory affairs and quality assurance, preferably within a manufacturing environment.
• Direct, hands-on experience authoring and managing FDA 510(k) submissions from preparation through submission and agency correspondence.
• Practical experience establishing, implementing, or maintaining a medical-device Quality Management System.
• Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical-device regulatory requirements.
• Experience managing manufacturing quality processes, supplier quality programs, corrective actions, document control, and audit activities.
• Strong understanding of FDA regulatory expectations and medical-device manufacturing compliance.
• Excellent written and verbal communication skills, with the ability to prepare technical regulatory documentation and communicate effectively with regulatory agencies.
• Ability to independently manage multiple priorities, assess regulatory risks, and drive projects to completion.
• Ability and willingness to travel periodically to company locations and other business-related destinations.

Requirements

• Develop, implement, and maintain regulatory strategies to support medical-device development, manufacturing, and commercialization.
• Personally author, prepare, and manage FDA 510(k) premarket notifications, including supporting documentation, regulatory assessments, agency responses, and applicable ongoing regulatory filings.
• Monitor changes in FDA regulations, guidance documents, and applicable industry standards to ensure continued compliance.
• Establish, implement, and maintain a Quality Management System (QMS) in accordance with FDA Quality Management System Regulation (QMSR) and ISO 13485 requirements.
• Oversee manufacturing quality assurance activities and ensure compliance with applicable regulatory and quality standards.
• Manage supplier qualification, supplier quality oversight, and ongoing supplier performance evaluations.
• Oversee document control, change management, nonconformance reporting, corrective and preventive actions (CAPA), and other quality system processes.
• Develop and maintain audit programs, including internal audits, supplier audits, and preparation for regulatory inspections.
• Lead responses to regulatory inspections, audit findings, and quality-related investigations.
• Identify compliance risks and implement appropriate corrective actions and process improvements.
• Collaborate with manufacturing, operations, engineering, and executive leadership to support regulatory compliance and quality objectives.
• Conduct periodic visits to company locations to evaluate quality systems, manufacturing compliance, and operational practices.
• Maintain accurate regulatory and quality documentation and ensure records are readily available for audits and inspections.
• Perform other duties as assigned.

Company Description