Regulatory Affairs Manager - Bilingual (Mandarin & English)

Who is CorDx？

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Description

We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements.

Responsibilities

· Prepare and submit 510(k) applications for IVD products to ensure timely market entry.

· Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed.

· Conduct regulatory risk assessments and develop mitigation strategies for IVD products.

· Stay updated with regulatory changes and ensure all IVD products comply with current regulations.

· Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions.

· Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization.

· Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance.

· Assist in reviewing marketing materials, contracts, or product information for Mandarin-speaking audiences.

· Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field.
• Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions.
• Strong understanding of FDA regulations, guidance documents, and processes related to IVD products.
• 10 year work experience.
• More than 5 years team management experience.
• Manage team subordinates more than 5.
• The average job tenure is 30 months.
• Life Science industry,IVD prefer.
• Less 7 companies, no consulting.
• Successful 510K submission cases.
• Ability to speak Mandarin at a professional level is essential for this role.
• Extensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Certification in quality management (e.g.,RAC ASQ CQE, CQA) is a plus.
• Experience in medical device IVD Quality Assurance is a plus.

Benefits

• Health Care Plan (Medical)
• 401K
• Paid Time Off and Paid Sick Leave
• Training & Development

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.