Director of Quality Assurance​/Regulatory Affairs

Overview

Hamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. Our focus is on developing ventilation technologies that prioritize safety, effectiveness, and lung protection. We are dedicated to easing the burden on healthcare professionals who work tirelessly every day, helping critically ill patients recover and regain their health.

We are committed to helping medical teams deliver the best respiratory care ‑ to anyone, anywhere.

• Provide value-added and solution-based support by implementing policies and procedures to maintain and improve manufacturing practices toward quality in a Medical Device and Scientific Equipment environment, ensuring that product meets corporate, regulatory, and customer standards.
• Maintain a system-wide Quality Assurance Program compliant with FDA regulations and other relevant global standards, including ISO 13485.
• Work with Product Management/R&D to complete design history file documentation FDA submissions.
• Define and lead the US regulatory strategy to support product development, lifecycle management, and commercial objectives.
• Serve as senior regulatory authority for US FDA matters, ensuring alignment with corporate risk tolerance, quality objectives, and business timelines.
• Advise executive leadership on regulatory risk, policy changes, and emerging FDA expectations.
• Lead and oversee all formal FDA engagements, including Pre-Submissions (Q-Subs), submission meetings, interactive reviews, deficiency responses, and appeals.
• Build and maintain constructive, credible relationships with FDA reviewers and branch leadership.
• Represent the organization during FDA inspections, audits, and regulatory enforcement actions related to submissions and regulatory compliance.
• Proactively identify and mitigate regulatory risks that could impact product clearance, approvals, or market access.
• Conduct product recalls, including customer notifications and any required FDA, Health Canada, or other global agency communications, as necessary.
• Conduct system-wide audits (system, process, safety/environmental, and stock audits) of all processes and methods used in the design, promotion, manufacture, packaging, storage, and distribution of product to ensure that all quality standards are met.
• Work with department heads on planning and implementation of resolutions and risk mitigations.
• Prepare and distribute reports on quality metrics to management and suggest appropriate improvements and corrective actions.
• Staff and maintain a well-trained workforce team at appropriate levels in accordance with established policies and procedures. Develop management and technical skills to preclude technical obsolescence.
• Contribute to cost reduction program by implementing cost savings based on analysis of defect history and customer service reports, and evaluations of product specs.
• Prepare and administer approved departmental operating budgets, long range goals, and ensure that it is complied with.
• Act as Management Representative for the Quality System (pursuant to FDA’s 21 CFR 820 and ISO 13485).
• Work closely with Swiss parent company, Hamilton Medical, AG, to coordinate and harmonize quality and regulatory systems and objectives.
• Work with product management and outside legal counsel on customer-related legal affairs.

Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:

• Ensure that processes needed for the quality management system are documented.
• Report to top management on the effectiveness of the quality management system and any need for improvements.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

The Management Representative currently appointed is the Director of Quality and Regulatory.

• Expert knowledge of Medical Device Regulatory Requirements (U.S. FDA, EU, and other applicable global agencies), Quality System requirements, and of physical measurements and…