SUMMARY

The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup. This position affords a seasoned professional independence and latitude for decision making accompanied by the accountability and high expectations requisite in an environment where every decision impacts our chances to win. You will join a small team who left great jobs to go “all in” with Kardion to bring a great product to market. Communication skills, humility, competitive spirit and team fit are paramount.
The Principal Regulatory Affairs Specialist is a senior technical expert and strategic problem solver within Kardion’s Regulatory Affairs team. This role is ideal for someone who thrives in ambiguity, synthesizes information across complex systems, and builds regulatory pathways from scratch. You will lead the execution of key U.S. FDA submissions—including IDEs, 510(k)s, and PMAs—for Class III cardiovascular medical devices. In this highly visible role, you’ll shape regulatory strategy, influence design and development decisions, and partner cross-functionally to position Kardion for long-term regulatory and commercial success. You are both a thinker and a doer—comfortable navigating gray space while driving clarity, precision, and results. Success in this hybrid environment requires exceptional planning and communication skills, ensuring alignment across global stakeholders and timelines.

SKILLS, QUALIFICATIONS & KEY KNOWLEDGE AREAS

• Bachelor’s degree in engineering, Life Sciences, or a related technical field required; advanced degree preferred.
• Minimum of 10 years of regulatory experience in the medical device industry, with at least 8 years focused on U.S. FDA Class III submissions and lifecycle management.
• Proven experience drafting and leading FDA IDEs, 510(k)s, and PMAs, including responding to agency feedback and managing submissions through clearance or approval.
• Experience working with contract manufacturing organizations (CMOs) is required; must be comfortable navigating regulatory responsibilities in outsourced environments with no flexibility.
• Demonstrated success with design and manufacturing transfer, particularly for complex medical devices with both electro-mechanical and disposable components.
• Experience in interventional cardiology or other Class III therapeutic areas is highly desired.
• Direct participation in FDA inspections, including both front-room leadership and back-room coordination, is highly desired.
• Strong judgment and decision-making skills, with the ability to operate independently while balancing strategic impact and regulatory risk.
• Exceptional communication and collaboration skills, with the ability to translate regulatory requirements across R&D, Quality, Clinical, and Executive teams.

• Design and execute regulatory strategies that support U.S. and global submissions across the product lifecycle, including new product introductions, updates, and process changes.
• Lead the development and authorship of FDA submissions—including IDEs, 510(k)s, and PMAs—as well as international dossiers such as Technical Files, with minimal oversight.
• Act as a strategic partner to cross-functional teams including R&D, Quality, Clinical, and Marketing, providing proactive regulatory guidance and influencing key design and development decisions.
• Identify regulatory risks early in the product development cycle and drive mitigation strategies aligned with business goals and compliance requirements.
• Review and approve product labeling, technical documentation, promotional materials, and marketing claims to ensure alignment with regulatory expectations.
• Serve as a primary liaison with FDA and other global regulatory authorities; represent Kardion in agency meetings and communications.
• Monitor and interpret evolving global regulatory requirements, translating them into practical implications for Kardion’s product pipeline and processes.
• Contribute to continuous improvement of regulatory systems, documentation practices, and QMS alignment; support audit readiness activities as needed.
• Mentor junior regulatory team members and contribute to cross-training efforts to build internal capability and resilience.
• Exercise sound, ethical judgment within all regulatory and quality frameworks.
• Perform other regulatory-related responsibilities as assigned.