Experience reviewing or responding to FDA information requests across CMC , patient-level data, investigator qualifications, and biomarker or endpoint evidence. * No conflict of interest with a ...
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Experience reviewing or responding to FDA information requests across CMC , patient-level data, investigator qualifications, and biomarker or endpoint evidence. * No conflict of interest with a ...
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Experience reviewing or responding to FDA information requests across CMC , patient-level data, investigator qualifications, and biomarker or endpoint evidence. * No conflict of interest with a ...
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
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FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
San Diego, CA ยท On-site
$120 - $170/hr
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
San Diego, CA ยท On-site
$120 - $170/hr
FDA Submissions * Lead preparation, review, and submission of FDA regulatory applications, including: * 510(k) Premarket Notifications * CLIA Categorization and CLIA Waiver submissions * Q ...
San Francisco, CA ยท On-site
$168K - $252K/yr
You will act as the Regulatory representative during internal and external audits (FDA, ISO). * Promotional Review: Review and approve labeling, marketing materials, and user manuals to ensure claims ...
San Francisco, CA ยท On-site
$168K - $252K/yr
You will act as the Regulatory representative during internal and external audits (FDA, ISO). * Promotional Review: Review and approve labeling, marketing materials, and user manuals to ensure claims ...
San Francisco, CA ยท On-site +1
$127K - $165K/yr
Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required * Demonstrated competency in developing risk based regulatory strategies required * Wearable medical ...
San Francisco, CA ยท On-site +1
$127K - $165K/yr
Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required * Demonstrated competency in developing risk based regulatory strategies required * Wearable medical ...
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
South San Francisco, CA ยท On-site
$229 - $267/hr
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
South San Francisco, CA ยท On-site
$229 - $267/hr
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
San Francisco, CA ยท On-site +1
$127K - $137K/yr
Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform * Familiarity with international regulatory models (Australia, UK, EU) * An existing network spanning biotech ...
San Francisco, CA ยท On-site +1
$127K - $137K/yr
Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform * Familiarity with international regulatory models (Australia, UK, EU) * An existing network spanning biotech ...
South San Francisco, CA ยท On-site
$229 - $267/hr
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
South San Francisco, CA ยท On-site
$229 - $267/hr
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
... FDA/OPDP guidance) * Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while ...
San Francisco, CA ยท On-site +1
$127K - $137K/yr
Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform * Familiarity with international regulatory models (Australia, UK, EU) * An existing network spanning biotech ...
San Francisco, CA ยท On-site +1
$127K - $137K/yr
Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform * Familiarity with international regulatory models (Australia, UK, EU) * An existing network spanning biotech ...
Lead Quality Management Review activities and appropriately escalate significant quality and ... Advanced knowledge of cGMP requirements, FDA regulations, and ICH guidelines applicable to contract ...
New
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Lead Quality Management Review activities and appropriately escalate significant quality and ... Advanced knowledge of cGMP requirements, FDA regulations, and ICH guidelines applicable to contract ...
New
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
... FDA audits, ensuring they are accurate and complete Proofreads final submission and print layouts Provides editorial review of marketing materials Provide PRC SOP and system training to key ...
... FDA audits, ensuring they are accurate and complete Proofreads final submission and print layouts Provides editorial review of marketing materials Provide PRC SOP and system training to key ...
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
Carlsbad, CA ยท On-site
$66K - $99K/yr
The Quality Control Scientific Reviewer provides independent, data-driven review and oversight ... Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH ...
San Francisco, CA ยท On-site
$130 - $190/hr
* Work alongside software engineers to author, review, and maintain comprehensive design control ... Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines. * Experience ...
San Francisco, CA ยท On-site
$130 - $190/hr
* Work alongside software engineers to author, review, and maintain comprehensive design control ... Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines. * Experience ...
Fullerton, CA ยท On-site
$130K - $140K/yr
Label review and regulatory compliance verification. * Customer, supplier, and third-party audit management. LACF Certification Requirements * Must be certified in FDA-recognized Low-Acid Canned Food ...
Fullerton, CA ยท On-site
$130K - $140K/yr
Label review and regulatory compliance verification. * Customer, supplier, and third-party audit management. LACF Certification Requirements * Must be certified in FDA-recognized Low-Acid Canned Food ...
$10.44 - $13.85
1% of jobs
$13.85 - $17.25
13% of jobs
$17.25 - $20.66
4% of jobs
$22.01 is the 25th percentile. Wages below this are outliers.
$20.66 - $24.07
18% of jobs
$24.07 - $27.48
14% of jobs
The median wage is $27.58 / hr.
$27.48 - $30.88
17% of jobs
$30.88 - $34.29
7% of jobs
$34.68 is the 75th percentile. Wages above this are outliers.
$34.29 - $37.70
12% of jobs
$37.70 - $41.11
8% of jobs
$41.11 - $44.51
5% of jobs
$44.51 - $47.92
1% of jobs
$10
$29
$47
| Aspect | Fda Reviewer | Fda Investigator |
|---|---|---|
| Primary Role | Review and evaluate regulatory submissions for safety, efficacy, and compliance of medical products | Conduct inspections and investigations to ensure compliance with FDA regulations |
| Work Environment | Office-based, reviewing documents and data | Fieldwork, inspecting facilities and conducting interviews |
| Required Credentials | Typically a background in life sciences, healthcare, or related fields; often requires a degree and regulatory knowledge | Similar credentials; often a degree in sciences, with training in inspection procedures |
While both roles work within the FDA and require scientific knowledge, Fda Reviewers focus on evaluating submissions for approval, whereas Fda Investigators conduct on-site inspections to verify compliance. Both positions are essential for ensuring the safety and efficacy of medical products, but they differ in daily tasks and work settings.
For Fda Reviewer jobs in California, the most frequently searched job titles are:
The top searched job categories for Fda Reviewer jobs in California are:
Cities in California with the most Fda Reviewer job openings:

$170/hr
Full-time
Posted 5 days ago
About the job
Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.
Position: Clinical Regulatory Expert
Type: Contract
Compensation: $130–$170/hour
Location: Remote
Commitment: 20–25 hours/week
Role Responsibilities
Qualifications
Must-Have
Preferred
Application Process (Takes 20–30 mins to complete)
Resources & Support
PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.