Executive Search Consultant at The Mullings Group
About
Aquapass is a pioneering medical technology company dedicated to revolutionizing the treatment of fluid overload in patients with chronic heart failure (CHF) and end-stage renal disease (ESRD). Their flagship product is a non-invasive, drug-free system that utilizes a wearable suit to induce natural perspiration, allowing for fluid removal without burdening the kidneys.
Key Responsibilities
* Lead the development and execution of regulatory strategies for 510(K) submission.
* Serve as the primary liaison with the FDA and other global regulatory bodies.
* Prepare, review, and submit regulatory documentation including IDEs, PMAs, technical files, and design dossiers.
* Provide regulatory guidance to cross-functional teams, including R&D, Clinical, Quality, and Marketing, throughout the product lifecycle.
* Monitor and interpret evolving global regulatory requirements, assessing their impact on product development and commercialization.
* Support clinical trial strategy and execution from a regulatory perspective, including protocol review and regulatory submissions.
* Lead regulatory audits and inspections, ensuring readiness and compliance.
Qualifications
* Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred).
* 8+ years of regulatory affairs experience in the medical device industry, with a strong focus on Class III cardiac devices.
* Proven track record of leading successful PMA & 510(k) submissions and interactions with the FDA.
* Deep understanding of U.S. and international regulatory requirements (e.g., FDA, EU MDR, Health Canada).
* Experience supporting clinical trials and working with cross-functional teams in a fast-paced environment.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Strategy/Planning, Writing/Editing, and Quality Assurance
Industries
* Medical Equipment Manufacturing
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