Director of Regulatory Affairs

Company Description Coramaze Technologies Petah Tikva, Israel is an emerging medical technology company focused on developing innovative solutions that improve patient outcomes and advance clinical practice. The organization operates in a highly regulated environment, emphasizing quality, safety, and compliance in all aspects of product development and commercialization. Team members collaborate closely across functions to bring medical products to market efficiently while meeting global regulatory standards. The company values integrity, scientific rigor, and a culture of continuous improvement, providing professionals with opportunities for impact and growth.

Role Description The Director of Regulatory Affairs is a full-time, on-site role based in Irvine, CA, responsible for leading regulatory strategy and execution for companies' product portfolio. This role oversees the planning, preparation, and submission of regulatory filings to domestic and international authorities, ensuring compliance throughout the product lifecycle. Day-to-day responsibilities include interpreting and applying regulatory requirements, advising cross-functional teams on regulatory pathways, and collaborating with R&D, quality, clinical, and commercial teams to support development and market access. The Director will manage regulatory risk assessments, maintain awareness of evolving regulations and standards, and represent the company in interactions with regulatory agencies and notified bodies. This role also involves mentoring regulatory staff, establishing best practices, and contributing to long-term corporate strategy from a regulatory perspective.

Qualifications

• Candidates should possess strong expertise in OUS/US Regulatory Requirements and Regulatory Affairs, including interpretation and application of medical device or healthcare regulations.

• Candidates should possess skills in Regulatory Strategy and Regulatory Submissions, with demonstrated experience developing regulatory pathways and leading successful filings (e.g., 510(k), PMA, CE marking, or equivalent).

• Candidates should possess Cross-functional Team Leadership skills, with a proven ability to collaborate effectively with R&D, quality, clinical, operations, and commercial teams.

• Extensive experience in regulatory affairs within the medical device, biotech, or pharmaceutical industry, including leadership roles and responsibility for complex projects.

• Strong analytical, problem-solving, and risk assessment skills, with attention to detail and a structured, evidence-based approach to decision-making.

• Excellent written and verbal communication skills, including the ability to prepare clear regulatory documentation and communicate with regulators and internal stakeholders.

• Bachelor’s degree in a scientific, engineering, or healthcare-related field; an advanced degree or regulatory certification (e.g., RAC) is preferred.

• Demonstrated ability to operate in a fast-paced environment, manage multiple priorities, and uphold ethical standards and compliance-focused culture.