New Carrollton, MD Overview Bizzell is a consulting, strategy, investment and technology firm with ... Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
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New Carrollton, MD Overview Bizzell is a consulting, strategy, investment and technology firm with ... Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
Quick apply
New Carrollton, MD Overview Bizzell is a consulting, strategy, investment and technology firm with ... Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
New Carrollton, MD Overview Bizzell is a consulting, strategy, investment and technology firm with ... Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
New Carrollton, MD Overview Bizzell is a consulting, strategy, investment and technology firm with ... Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
Monmouth Junction, NJ ยท On-site
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 ...
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Monmouth Junction, NJ ยท On-site
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 ...
Montrose, CA ยท On-site
Provide support during audits and inspections to ensure systems meet regulatory expectations (FDA ... Consultant I (Entry-Level / Junior) * Experience: 0-3 years CSV or validation experience in GMP ...
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Montrose, CA ยท On-site
Provide support during audits and inspections to ensure systems meet regulatory expectations (FDA ... Consultant I (Entry-Level / Junior) * Experience: 0-3 years CSV or validation experience in GMP ...
Washington, DC ยท On-site
$105K - $130K/yr
Work with ARPA-H's Office of Commercialization to support regulatory consulting needs * Assist in ... with FDA * 2-3 years in ARPA setting (preferred) * Experience with contracts research and ...
Washington, DC ยท On-site
$105K - $130K/yr
Work with ARPA-H's Office of Commercialization to support regulatory consulting needs * Assist in ... with FDA * 2-3 years in ARPA setting (preferred) * Experience with contracts research and ...
Somerville, NJ ยท On-site
Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area ... Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, based on project ...
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Somerville, NJ ยท On-site
Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area ... Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, based on project ...
Ann Arbor, MI ยท On-site
... consultation and preparing and submitting Medical Device Master File (MAF) packages and updates ... Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good ...
Ann Arbor, MI ยท On-site
... consultation and preparing and submitting Medical Device Master File (MAF) packages and updates ... Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good ...
Dallas, TX ยท On-site
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
Dallas, TX ยท On-site
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
Position Overview: Indomo is seeking an experienced CMC consultant to execute Chemistry ... Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings). Qualifications:
Position Overview: Indomo is seeking an experienced CMC consultant to execute Chemistry ... Prepare for and support FDA interactions (e.g., IND, EOP2, Type C meetings). Qualifications:
CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary ... Ensure validation activities align with FDA, GAMP5, and GxP compliance requirements * Collaborate ...
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CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary ... Ensure validation activities align with FDA, GAMP5, and GxP compliance requirements * Collaborate ...
Newark, NJ ยท On-site
SAP EWM Consultant (Pharma) Location: NJ (Onsite) Exp : 14+yrs We are seeking an experienced SAP ... FDA compliance, Serialization, and Track & Trace processes Experience in warehouse operations ...
Newark, NJ ยท On-site
SAP EWM Consultant (Pharma) Location: NJ (Onsite) Exp : 14+yrs We are seeking an experienced SAP ... FDA compliance, Serialization, and Track & Trace processes Experience in warehouse operations ...
From clinical trials to regulatory, consulting, and market access, every clinical development ... Ensure compliance with FDA, EMA, HC regulations, ICH guidelines, and applicable global regulatory ...
From clinical trials to regulatory, consulting, and market access, every clinical development ... Ensure compliance with FDA, EMA, HC regulations, ICH guidelines, and applicable global regulatory ...
Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite) Location: Concord, NC ... FDA 21 CFR Part 11 * GAMP5 Guidelines * GxP Requirements * Data Integrity Standards * IT Governance ...
Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite) Location: Concord, NC ... FDA 21 CFR Part 11 * GAMP5 Guidelines * GxP Requirements * Data Integrity Standards * IT Governance ...
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
San Diego, CA ยท On-site
Role: SAP WM Consultant (ECC to S/4HANA Migration) Location: Southern California (Hybrid/Onsite ... Medical Device, Life Sciences, or FDA-regulated manufacturing industry experience preferred.
San Diego, CA ยท On-site
Role: SAP WM Consultant (ECC to S/4HANA Migration) Location: Southern California (Hybrid/Onsite ... Medical Device, Life Sciences, or FDA-regulated manufacturing industry experience preferred.
Through our expertise, insight, consulting and management skills, we accelerate breakthrough ... Handle FDA Type A, Type B, and Type C meetings. * Engage in all phases of drug development, from ...
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Through our expertise, insight, consulting and management skills, we accelerate breakthrough ... Handle FDA Type A, Type B, and Type C meetings. * Engage in all phases of drug development, from ...
Consultant, Food Safety and Quality Assurance Intertek Alchemy is seeking a Consultant to join our ... Support clients in addressing USDA-FSIS and FDA compliance requirements, including responses to ...
Consultant, Food Safety and Quality Assurance Intertek Alchemy is seeking a Consultant to join our ... Support clients in addressing USDA-FSIS and FDA compliance requirements, including responses to ...
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...
Consultant, Food Safety and Quality Assurance Intertek Alchemy is seeking a Consultant to join our ... Support clients in addressing USDA-FSIS and FDA compliance requirements, including responses to ...
Consultant, Food Safety and Quality Assurance Intertek Alchemy is seeking a Consultant to join our ... Support clients in addressing USDA-FSIS and FDA compliance requirements, including responses to ...
$153K - $202K/yr
This role will translate complex FDA, EU IVDR, and other global regulatory requirements into ... Consulting Services * Serve as the CDx regulatory subject matter expert for strategic positioning ...
$153K - $202K/yr
This role will translate complex FDA, EU IVDR, and other global regulatory requirements into ... Consulting Services * Serve as the CDx regulatory subject matter expert for strategic positioning ...
$10.34 - $17.31
5% of jobs
$17.31 - $24.28
6% of jobs
$28.14 is the 25th percentile. Wages below this are outliers.
$24.28 - $31.25
24% of jobs
The median wage is $35.17 / hr.
$31.25 - $38.22
25% of jobs
$38.22 - $45.19
14% of jobs
$45.39 is the 75th percentile. Wages above this are outliers.
$45.19 - $52.16
9% of jobs
$52.16 - $59.13
5% of jobs
$59.13 - $66.11
3% of jobs
$66.11 - $73.08
3% of jobs
$73.08 - $80.05
2% of jobs
$80.05 - $87.02
2% of jobs
$10
$41
$87
As an FDA Consultant, your days often involve preparing and reviewing regulatory submissions, advising clients on compliance strategies, and staying up-to-date with evolving FDA requirements. You'll work closely with clients in pharmaceutical, medical device, or biotech companies to interpret regulations, conduct gap analyses, and support product development from early stages through post-market compliance. Collaboration with cross-functional teams, such as research, quality assurance, and legal, is common to ensure all processes and documentation meet FDA standards. The work environment is typically a mix of independent analysis and interactive client meetings, offering a balance between technical expertise and strategic consulting.
To thrive as an FDA Consultant, you need in-depth knowledge of FDA regulations and guidelines, regulatory submission processes, and a relevant science or healthcare background. Familiarity with regulatory databases, document management systems, and certifications like RAC (Regulatory Affairs Certification) are highly valued in this field. Strong analytical skills, attention to detail, and effective communication are key soft skills for advising clients and coordinating with multidisciplinary teams. These skills are essential for ensuring clients achieve compliance, avoid costly delays, and succeed in the highly regulated life sciences industry.
An FDA Consultant helps businesses navigate FDA regulations to ensure compliance with federal laws related to drugs, medical devices, food, and other regulated products. They provide expert guidance on submissions, approvals, inspections, and regulatory strategies. Their role is crucial for companies seeking to bring products to market while meeting all legal requirements.
Part-time
Re-posted 19 days ago
Location: Statewide, North Carolina
Job Type: Contract, Part-Time
Headquarters: New Carrollton, MD
Overview
Bizzell is a consulting, strategy, investment and technology firm with a mission to improve lives and accelerate positive change. We deliver award-winning services to a diverse portfolio of clients to help build healthy, secure, connected and sustainable communities in our nation and around the world. Bizzellโs multi-disciplinary team works in health solutions, workforce innovation, managed services, and global programs. Specifically, they offer expertise in program management, research and evaluation, communication and outreach, training and technical assistance, policy analysis, and development.
Key Responsibilities
Compliance Inspections & Enforcement
Data Collection & Reporting
Training & Professional Development
Why Join Us?
Interested candidates should submit their resume and cover letter, detailing relevant experience and qualifications.
Education & Experience
Additional Requirements
Technical & Administrative Skills
Sourced by ZipRecruiter
11 - 50 Employees
Lanham, MD, US
2010