Director of Regulatory Affairs

Job Description

Job Responsibilities:

1. Develop and execute FDA registration strategies for all products to ensure timely registration for market launch.
2. Research and gather FDA regulatory requirements for in vitro diagnostic products to inform product and clinical development.
3. Author Pre-submission documents and communicate with the FDA on product registration questions.
4. Review the technical documentation for product registration to ensure compliance with regulations and technical standards.
5. Compile, organize, prepare, and review product registration documentation.
6. Handle e-STAR electronic submissions for 510K products, ensuring compliance and efficiency.
7. Coordinate internal resources, track and report on the progress of product registration, and address issues raised by FDA reviewers.
8. Manage the filing of 510K-exempt products, submission of 510K FDA registration documents, annual company registration, payment of FDA fees, and small business designation.
9. Oversee the company’s quality management system and review quality system documentation.
10. Support FDA quality inspection, addressing any issues identified during inspections.
11. Provide periodic updates and training on regulatory changes related to product registration.

Qualifications:

1. Master’s degree in biology, pharmaceuticals, or related fields, a minimum of 5 years of experience in FDA medical device registration.
2. Proficient in FDA regulations for in vitro diagnostic products; candidates with prior experience in 510K submissions for IVD products are preferred.
3. Hands-on experience with FDA Quality System Regulation 21 CFR 820, ISO 13485, and ISO 14971 standards.