Regulatory Affairs Specialist

Pi-Cardia is a fast-growing medical device startup developing innovative cardiovascular technologies.

We are seeking an experienced Regulatory Affairs Specialist to support global regulatory activities for innovative medical devices. The successful candidate will be responsible for regulatory submissions, product lifecycle management, change control activities, and ensuring compliance with applicable regulations and standards. This role will support market access and ongoing regulatory compliance in key international markets, including the United States and Europe.

Key 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.