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Fda Consulting Jobs (NOW HIRING)

Viking Cruises US

FDA Senior Analyst

Los Angeles, CA · On-site +1

$105K - $120K/yr

Viking Cruises is seeking a Financial Data Analytics (FDA) Senior Financial Analyst (SFA) to join ... consulting, or a related field. * Strong understanding of accounting principles and financial ...

Apex Systems

FDA Customer Tech

Silver Spring, MD · On-site

$17.75 - $24/hr

Job#: 3043365 FDA Customer Tech If interested, please send most updated resume to Location: Silver ... Everforth Apex has a dedicated customer service team for our Consultants that can address questions ...

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How much do fda consulting jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for fda consulting in the United States is $52.51, according to ZipRecruiter salary data. Most workers in this role earn between $21.88 and $69.71 per hour, depending on experience, location, and employer.

What is an FDA consulting?

An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.

What does an FDA consultant do?

As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

What skills and qualifications are needed for FDA consulting?

To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.

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fda consulting jobs near you
Infographic showing various Fda Consulting job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 84% Full Time, 9% Part Time, and 6% Contract. Highlights an 83% Physical, 6% Hybrid, and 11% Remote job distribution, with an average salary of $109,227 per year, or $52.5 per hour.

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

Essenlix

Monmouth Junction, NJ • On-site

Full-time

Medical, Retirement, PTO

Re-posted 21 days ago

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.