Pi-Cardia

Description 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 The Controller is a key member of the finance team, responsible for supporting ongoing accounting processes and the company’s financial reporting, including consolidated financial statements. The role includes working with financial data, performing controls and reconciliations, and preparing reports while ensuring accuracy and meeting deadlines. This position has a direct impact on the quality of financial information and supports data-driven decision-making within the organization. The role requires collaboration with internal stakeholders and includes ongoing interaction with finance team members in the United States, as well as coordination across different time zones due to the company’s global operations. Responsibilities • Ongoing management of financial systems and collaboration with internal stakeholders, including regular coordination with US-based finance team members and cross-functional teams • Ownership of month-end and quarter-end closing processes, including participation in the preparation of monthly, quarterly, and annual Consolidated financial statements • Professional management and oversight of the bookkeeping team, including task allocation, guidance, and review of work • Support of external audit processes, including preparation of audit schedules and interaction with auditors • Execution of internal controls and validation of financial data accuracy and completeness • Participation in the implementation and continuous improvement of financial processes and controls Requirements • Israeli Certified Public Accountant (CPA) • 2–3 years of post-internship experience, including prior experience as an Assistant Controller or Controller within a company • Ability to work both independently and as part of a team, with a high level of ownership, a proactive approach, and strong prioritization and task management skills in a dynamic environment • High level of English - must • Experience managing or leading a team • Hands-on experience with Priority ERP- Advantage • Strong attention to detail and ability to maintain accuracy in a fast-paced, dynamic environment • Advanced Excel skills and familiarity with financial systems and reporting tools • Excellent interpersonal skills Preferred Qualifications • Experience working in a multinational company is an advantage • Experience with technology companies is an advantage

Description 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 The QC Technician is responsible for performing incoming and in-process inspections to ensure product quality and compliance with company standards. The role includes working in a cleanroom environment, documenting inspection results, and supporting manufacturing through accurate, detail-oriented quality control activities. Responsibilities • Perform incoming and in-process inspections • Work in a cleanroom environment • Complete inspection reports and maintain documentation using Microsoft Office tools Requirements • Experience in operating measuring tools • Experience in a medical device company • Ability to read technical drawings • Ability to work in a cleanroom environment • Ability to read and understand both English and Hebrew • Strong attention to detail in identifying defects • High level of accuracy and precision • Strong team player • High level of self-discipline • Willingness to work evening shifts

Description 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. Requirements • 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.