Regulatory Affairs Specialist

About Pi-Cardia

Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture.

Position Overview

We are looking for an experienced Regulatory Affairs Specialist to join our growing Regulatory Affairs team. In this role, you will help drive global regulatory strategies and ensure compliance throughout the product lifecycle of our innovative cardiovascular medical devices. You will work closely with cross-functional teams to support product development, regulatory submissions, design changes, and market access, playing a key role in bringing life-changing technologies to patients around the world.

Responsibilities

• Prepare, review, and maintain regulatory submissions and registrations for medical devices in global markets, with a primary focus on the U.S. (FDA) and European Union (EU MDR).
• Support regulatory strategy development for new product introductions, design changes, and lifecycle management activities.
• Manage Engineering Change Orders (ECOs) from a regulatory perspective, including assessment of regulatory impact, documentation updates, and submission requirements.
• Compile, maintain, and update technical documentation, regulatory dossiers, and supporting documentation in accordance with regulatory requirements.
• Ensure compliance with EU MDR, FDA regulations, and applicable international standards throughout the product lifecycle.
• Monitor changes in regulatory requirements and assess their impact on existing and future products.
• Collaborate cross-functionally with R&D, Quality Assurance, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.
• Support regulatory assessments, risk management activities, labeling reviews, and design change evaluations.
• Participate in audits and inspections and provide regulatory support for quality management system activities.
• Maintain regulatory records and ensure timely renewals, registrations, and submissions.

• Bachelor's degree in Life Sciences, Biomedical Engineering, Engineering, Pharmacy, or a related field.
• 4–8 years of Regulatory Affairs experience within the medical device industry.
• Proven experience with medical device regulatory submissions and registrations in the United States and Europe.
• Strong knowledge of FDA medical device regulations and European Medical Device Regulation (EU MDR 2017/745).
• Hands-on experience managing product changes and ECO processes from a regulatory affairs perspective.
• Familiarity with ISO 13485, ISO 14971, and other applicable medical device standards.
• Experience supporting product development, design changes, and post-market regulatory activities.
• Excellent organizational, analytical, and communication skills.
• Strong written and verbal English communication skills.
• Ability to work independently and effectively within a multidisciplinary environment.
• Experience in the cardiovascular medical device field.
• Experience with Class III and/or implantable medical devices.
• Regulatory Affairs Certification (RAC) or equivalent professional certification.
• Experience with additional international markets such as Canada, UK, Australia, Japan, or other global regions.