Hybrid Senior Regulatory Affairs Leader - FDA Submissions

KARDION; Irvine (CA); Hybrid; USD 130,000 - 160,000; Full time

Job summary

A clinical stage startup in Irvine, CA is seeking a Principal Regulatory Affairs Specialist to lead the execution of key U.S. FDA submissions for Class III cardiovascular medical devices. The role involves developing regulatory strategies, partnering with cross-functional teams, and guiding submissions with minimal oversight. Candidates should have extensive regulatory experience and strong communication skills to thrive in a dynamic environment.

Qualifications

• 10+ years of regulatory experience in medical devices, with 8 years focused on FDA Class III submissions.
• Proven experience in drafting and leading FDA IDEs, 510(k)s, and PMAs.
• Ability to operate independently while balancing strategic impact and regulatory risk.

Responsibilities

• Lead execution of key U.S. FDA submissions including IDEs, 510(k)s, and PMAs.
• Develop regulatory strategies that support U.S. and global submissions.
• Act as a strategic partner to cross-functional teams, providing regulatory guidance.

Skills

Strategic problem solving

Regulatory submission experience

Communication skills

Judgment and decision-making

Education

Bachelor's degree in engineering, Life Sciences, or related field

Advanced degree preferred

Job description

A clinical stage startup in Irvine, CA is seeking a Principal Regulatory Affairs Specialist to lead the execution of key U.S. FDA submissions for Class III cardiovascular medical devices. The role involves developing regulatory strategies, partnering with cross-functional teams, and guiding submissions with minimal oversight. Candidates should have extensive regulatory experience and strong communication skills to thrive in a dynamic environment.