Position Overview
Berlin Heart is a 30-year-old, privately held leader in Class III pediatric ventricular assist devices, operating in the cardiovascular MedTech industry. Financially self-sustaining through a single family office, the company internally funds all R&D—no external capital needed. Our device received full FDA PMA approval in 2017, with clinical data supporting treatment of 300-350 pediatric patients annually across North America.
Media & Press
• Berlin Heart pediatric VAD saves infant’s life – ABC News feature
• New data presented on Berlin Heart EXCOR® at AHA Scientific Sessions – MedTech Insight
• Berlin Heart appoints Bob Kroslowitz as CEO – Official press release
We have partnered with Bob Kroslowitz, CEO, to hire a Head of Quality and Regulatory Affairs to lead U.S. QA/RA strategy and execution from its wholly owned subsidiary 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).
Position Description
We seek a hands-on QA/RA executive with deep Class III medical device expertise—ideally in cardiovascular or VAD technologies—to:
1. Lead all QA/RA functions, remediate FDA & ISO audit gaps, and improve audit readiness.
2. Collaborate daily with on-site logistics, service, and clinical teams.
3. Present quality and regulatory strategy at Board level as Management Representative.
4. Mentor and develop two direct reports.
5. Own U.S. supplier audits (annual travel to Berlin required).
This position is 100% on-site in The Woodlands, TX (relocation assistance available)
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Position Details
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Job Responsibilities
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Ensure North American facility compliance to the Quality Policy and all other external regulatory standards.
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Regulatory, Quality and Compliance management, monitoring high-level risk management policies, ensuring compliance.
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Strategic planning, defining overall corporate Quality and Regulatory strategy with CEO
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Lead a culture of operational excellence by example and spearhead continuous improvement initiatives.
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Direct report mentoring and development
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Coordinate Q/A and R/A activities with external consultants
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Identify and rectify potential risk areas.
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Prepare and manage (future) ISO and FDA audits.
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Preparation of US Regulatory Submissions
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Maintain the necessary documentation to assure Quality and Regulatory compliance
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Work with Engineering/Operations and Service Departments to review and approve all required documentation requirements for North American approvals
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Review of product changes and their impact upon regulatory submissions
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Evaluate labels and promotional materials to ensure conformity with local regulations
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Monitor regulatory environment and guarantee compliance with FDA, other regulatory authority requirements, and company standards
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Interact with R&D, QA, Manufacturing, Logistics, Clinical Affairs, Sales, Marketing, external consultants, and notified bodies.
Qualifications and Experience
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Master’s degree in engineering or business, or life sciences
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15 years of progressive experience, with a minimum of 10 years in senior leadership positions within a medical device or biotechnology environment
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Analytical skills, capable of driving decisions based on complex data analysis in a highly regulated environment,
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Solution driven problem solving abilities
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Knowledge of process improvement methodologies
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Expertise in quality management systems (QMS) and compliance to regulations and standards (ISO 13485)
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Understanding of FDA premarket submissions (510(k), PMA, De Novo), CE Marking, and international regulatory pathways.
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Familiarity with post-market surveillance, clinical trials, and risk management.
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Exceptional interpersonal and leadership skills that embody company values.
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Experience in a collaborative, team-oriented environment, with keen organizational skills.
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Company Overview
Berlin Heart develops, manufactures, and markets innovative ventricular assist devices (VADs) for mechanical circulatory support. The Berlin Heart portfolio of ventricular assist devices offers you the ability to treat your patients with uni- or biventricular support as bridge to recovery and bridge to transplantation. EXCOR Pediatric is clinically reliable for support times of a few days up to several years as well as supports pediatric patients of all ages, from newborns to adolescents, with outstanding clinical performance proven in over 2,300 pediatric patients worldwide.
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CEO
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