Jobs in Monmouth | Careers in Government

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Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)
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Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)
- Monmouth Junction, New Jersey 08852 United States
- Essenlix
- Sep 17, 2026
- Full Time
Essenlix

Government jobs offer stability, competitive benefits, and the chance to make a meaningful impact on your community and country. Whether you’re starting your career or seeking new opportunities, these roles provide pathways for growth, security, and service. Explore positions across a wide range of fields and take the first step toward a rewarding future in public service.
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Job Details
- Full Time
- Sep 17, 2026
Job Description
Job Description Job Description 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 RD, 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.
Job Description Job Description 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 RD, 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.
Apply Now View job
Share this job:
Please mention you found this employment opportunity on the CareersInGovernment.com job board.
Essenlix

Government jobs offer stability, competitive benefits, and the chance to make a meaningful impact on your community and country.

Whether you’re starting your career or seeking new opportunities, these roles provide pathways for growth, security, and service.

Explore positions across a wide range of fields and take the first step toward a rewarding future in public service.
Essenlix
- https://careersingovernment.com/categories/1138/federal-government-jobs/
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9 Jobs in Monmouth

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

Border Patrol Agent - Entry Level

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