Principal Regulatory Affairs Specialist

• 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.

• 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.

• This is a full-time, exempt hybrid position based in Irvine, CA, with three days per week onsite at our Irvine headquarters and two days remote.

• Physical Abilities: While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear up to 8 hours per day. Duties also involve daily keyboard/computer use. Specific vision abilities required by this job include close vision. The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Language Abilities: Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Work Environment: Employee will, on occasion, be required to travel (drive or fly) and may be exposed to outside weather conditions; close, distance, and peripheral vision are required along with the ability to adjust focus and depth perception. Noise levels may be high.
• Travel: domestic/US travel up to ~10% at peak times, including international travel to Germany up to twice a year.

Kardion