MedTech Startup · 4 weeks ago
Quality Assurance Regulatory Affairs Senior Manager
Greater Houston
Full-time
Onsite
Director/Executive
$150K/yr - $200K/yr
15+ years expMedTech Startup is a leader in Class III pediatric ventricular assist devices, operating in the cardiovascular MedTech industry. They are seeking a Senior Manager of Quality and Regulatory Affairs to lead U.S. QA/RA strategy, oversee compliance, and mentor a team, while reporting directly to the CEO.
Medical Device
Hiring Manager
Joseph Snyder
Responsibilities
Ensure North American facility compliance with the Quality Policy and all other external regulatory standards
Regulatory, Quality and Compliance management, monitoring high-level risk management policies, ensuring compliance
Strategic planning, defining overall corporate Quality and Regulatory strategy with CEO
Lead a culture of operational excellence by example and spearhead continuous improvement initiatives
Direct report mentoring and development
Coordinate Q/A and R/A activities with external consultants
Identify and rectify potential risk areas
Prepare and manage (future) ISO and FDA audits
Preparation of US Regulatory Submissions
Maintain the necessary documentation to assure Quality and Regulatory compliance
Work with Engineering/Operations and Service Departments to review and approve all required documentation requirements for North American approvals
Review of product changes and their impact upon regulatory submissions
Evaluate labels and promotional materials to ensure conformity with local regulations
Monitor regulatory environment and guarantee compliance with FDA, other regulatory authority requirements, and company standards
Interact with R&D, QA, Manufacturing, Logistics, Clinical Affairs, Sales, Marketing, external consultants, and notified bodies
Qualification
Required
Master's degree in engineering, business, or life sciences
15 years of progressive experience, with a minimum of 10 years in senior leadership positions within a medical device or biotechnology environment
Analytical skills, capable of driving decisions based on complex data analysis in a highly regulated environment
Solution-driven problem-solving abilities
Knowledge of process improvement methodologies
Expertise in quality management systems (QMS) and compliance with regulations and standards (ISO 13485)
Understanding of FDA premarket submissions (510(k), PMA, De Novo), CE Marking, and international regulatory pathways
Familiarity with post-market surveillance, clinical trials, and risk management
Exceptional interpersonal and leadership skills that embody company values
Experience in a collaborative, team-oriented environment, with keen organizational skills
Benefits
Relocation assistance available
Company
MedTech Startup
MedTech Startup is a community of entrepreneurs, investors, corporate strategics, service providers, and industry partners.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase