Job Description

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:

• Bachelors 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

Referrals increase your chances of interviewing at The Mullings Group by 2x

Get notified about new Regulatory Affairs Manager jobs in Greater Boston .

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Job Tags

Similar Jobs