MedTech Startup
Quality Assurance Regulatory Affairs Senior Manager
MedTech Startup, Houston, Texas, United States, 77246
Quality Assurance Regulatory Affairs Senior Manager
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Quality Assurance Regulatory Affairs Senior Manager
role at
MedTech Startup
We are a 30‑year‑old, privately held leader in Class III pediatric ventricular assist devices, operating in the cardiovascular MedTech industry. Our device received full FDA PMA approval in 2017, with clinical data supporting treatment of 300‑350 pediatric patients annually across North America.
Position Overview We seek a hands‑on QA/RA executive with deep Class III medical device expertise—ideally in cardiovascular or VAD technologies—to lead U.S. QA/RA strategy and execution from our headquarters in The Woodlands, TX. Reporting directly to the CEO and overseeing two QA/RA Associates, this position will serve as Management Representative to the Board, close audit findings, and drive continuous compliance for our Class III pediatric ventricular assist device (VAD).
Job Responsibilities
Lead all QA/RA functions, remediate FDA & ISO audit gaps, and improve audit readiness.
Collaborate daily with on‑site logistics, service, and clinical teams.
Present quality and regulatory strategy at Board level as Management Representative.
Mentor and develop two direct reports.
Own U.S. supplier audits (annual travel to Berlin required).
Ensure North American facility compliance with the Quality Policy and all external regulatory standards.
Strategic planning and defining overall corporate Quality and Regulatory strategy with CEO.
Lead a culture of operational excellence by example and spearhead continuous improvement initiatives.
Coordinate Q/A and R/A activities with external consultants.
Identify and rectify potential risk areas.
Prepare and manage future ISO and FDA audits.
Prepare U.S. regulatory submissions.
Maintain documentation to assure Quality and Regulatory compliance.
Work with Engineering/Operations and Service Departments to review and approve all required documentation for North American approvals.
Review product changes and their impact on regulatory submissions.
Evaluate labels and promotional materials for regulatory conformity.
Monitor regulatory environment and guarantee compliance with FDA and other regulatory authorities.
Interact with R&D, QA, manufacturing, logistics, clinical affairs, sales, marketing, external consultants, and notified bodies.
Qualifications
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.
Strong 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 pre‑market 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.
Location and Travel 100% on‑site in The Woodlands, TX. Relocation assistance available.
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Quality Assurance Regulatory Affairs Senior Manager
role at
MedTech Startup
We are a 30‑year‑old, privately held leader in Class III pediatric ventricular assist devices, operating in the cardiovascular MedTech industry. Our device received full FDA PMA approval in 2017, with clinical data supporting treatment of 300‑350 pediatric patients annually across North America.
Position Overview We seek a hands‑on QA/RA executive with deep Class III medical device expertise—ideally in cardiovascular or VAD technologies—to lead U.S. QA/RA strategy and execution from our headquarters in The Woodlands, TX. Reporting directly to the CEO and overseeing two QA/RA Associates, this position will serve as Management Representative to the Board, close audit findings, and drive continuous compliance for our Class III pediatric ventricular assist device (VAD).
Job Responsibilities
Lead all QA/RA functions, remediate FDA & ISO audit gaps, and improve audit readiness.
Collaborate daily with on‑site logistics, service, and clinical teams.
Present quality and regulatory strategy at Board level as Management Representative.
Mentor and develop two direct reports.
Own U.S. supplier audits (annual travel to Berlin required).
Ensure North American facility compliance with the Quality Policy and all external regulatory standards.
Strategic planning and defining overall corporate Quality and Regulatory strategy with CEO.
Lead a culture of operational excellence by example and spearhead continuous improvement initiatives.
Coordinate Q/A and R/A activities with external consultants.
Identify and rectify potential risk areas.
Prepare and manage future ISO and FDA audits.
Prepare U.S. regulatory submissions.
Maintain documentation to assure Quality and Regulatory compliance.
Work with Engineering/Operations and Service Departments to review and approve all required documentation for North American approvals.
Review product changes and their impact on regulatory submissions.
Evaluate labels and promotional materials for regulatory conformity.
Monitor regulatory environment and guarantee compliance with FDA and other regulatory authorities.
Interact with R&D, QA, manufacturing, logistics, clinical affairs, sales, marketing, external consultants, and notified bodies.
Qualifications
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.
Strong 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 pre‑market 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.
Location and Travel 100% on‑site in The Woodlands, TX. Relocation assistance available.
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