Hamilton Medical · 5 days ago
Director of Quality Assurance/Regulatory Affairs
US-NV
Full-time
Onsite
Director/Executive
10+ years expHamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. The Director of Quality Assurance/Regulatory Affairs is responsible for ensuring that product quality levels conform to regulatory and customer standards while overseeing compliance with all regulatory requirements.
Health CareMedical
Responsibilities
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
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
Qualification
Required
B.S. or M.S. in Physical Science, Engineering, or related field required
Minimum of ten years of industrial quality assurance/regulatory affairs experience required
Minimum of five years management at department level required
Expert knowledge of Medical Device Regulatory Requirements (U.S. FDA, EU, and other applicable global agencies), Quality System requirements, and of physical measurements and statistical methods
Strong and credible reputation with peers, with the FDA and other regulatory agencies, with customers, and with registrars
Proven track record of authoring, reviewing, and approving high-quality 510(k) submissions, including substantial equivalence arguments, intended use, labeling, and responses to FDA deficiencies
Track record of managing and completing projects and tasks on time and within budget
Accountable for the success or failure of the total quality assurance operation and for the proper expenditure and management of annual budget
Position requires exerting up to 10 pounds of force occasionally and/or negligible amount of force to lift, carry, push, pull, or otherwise move objects
Benefits
Medical, dental, vision insurance
Paid vacation time
Paid sick time
Disability insurance
401k
Tuition reimbursement
And more
Company
Hamilton Medical
Hamilton Medical develops intelligent ventilation solutions, devices and consumables for the ventilation of all critically ill patients.
501-1000 employees
H1B Sponsorship
Hamilton Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageLeadership Team
Robert Hamilton
CEO
Recent News
PR Newswire UK
2025-11-11
Company data provided by crunchbase