Regulatory Affairs Lead IVD & Specialist (Mandarin)

CorDx, a global biotechnology company headquartered in San Diego, CA, is seeking a Regulatory Affairs Lead specializing in In Vitro Diagnostics (IVD) and 510(k) submissions. This role is integral to the regulatory team, focusing on ensuring compliance and facilitating market entry for innovative diagnostic products.

The Regulatory Affairs Lead will oversee the preparation, review, and submission of regulatory documents, including 510(k) applications and technical files, to regulatory agencies. Responsibilities encompass ensuring product compliance with FDA regulations, ISO 13485 standards, and other international requirements. The role involves conducting regulatory assessments for product changes, proposing appropriate regulatory pathways, and maintaining comprehensive records of all regulatory submissions and correspondence. Additionally, the lead will support preparations for regulatory agency meetings, audits, and inspections.

Candidates must possess a Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field, along with a minimum of 5 years of experience in regulatory affairs within the medical device or IVD industry. Proficiency in 510(k) submissions and regulatory documentation processes is essential. Strong organizational and project management skills, excellent communication abilities, and attention to detail are required. Fluency in Mandarin is preferred to facilitate communication with international partners.

CorDx offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company contributions, and a flexible paid time off policy. The company fosters a collaborative and innovative work environment, providing opportunities for professional growth and development in the rapidly evolving field of biotechnology.