Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)

About Essenlix Corporation:

Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing.

Our overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our U.S. -based quality management system and integrating global operations as we transition from development to commercialization in preparation for FDA clearance and international market expansion.

Position Summary:

We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.

Key Responsibilities:

Regulatory Affairs:

• Lead preparation and submission of FDA 510(k) applications.
• Coordinate CROs and external consultants.
• Prepare DHF, risk management, clinical studies, labeling, and technical files.
• Serve as primary contact with FDA.

Quality Management System (QMS):

• Lead remediation of U.S. QMS.
• Ensure compliance with FDA QSR and ISO 13485.
• Harmonize U.S. and China quality systems.
• Manage document control, CAPA, training, and audits.

Cross-Border Manufacturing:

• Support ISO 13485-certified China facility.
• Prepare sites for FDA inspections.
• Manage quality agreements.
• Support design transfer and validation.

Cross-Functional Leadership:

• Partner with R&D, manufacturing, and operations.
• Support design controls.
• Provide regulatory guidance.
• Train internal teams.

Qualifications:

Required:

• Bachelor’s degree in related field.
• 5+ years regulatory/quality experience.
• FDA 510(k) and CLIA experience.
• Knowledge of QSR, ISO 13485, ISO 14971.
• CRO coordination experience.

Preferred:

• Hematology/CBC related product experience.
• FDA foreign inspection experience.
• QMS remediation experience.
• Mandarin proficiency.
• RAC certification.

Compensation & Benefits:

• Competitive salary.
• 401(k).
• Health insurance.
• PTO.