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Fda Contractor Jobs in California (NOW HIRING)

Lancesoft

Quality Engineer I

Pleasanton, CA · On-site

$30 - $33.82/hr

S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO ... employees, customers, contractors, and vendors. * 0-3 years exp - supports the design ...

Abbott

Training Coordinator

Alameda, CA · On-site

$32 - $35/hr

S. Food and Drug Administration (FDA), company Standard Operating Procedures (SOPs), and Detailed ... employees, customers, contractors, and vendors. * Performs other essential functions and ...

Generis TEK Inc.

Quality Engineer

Pleasanton, CA · On-site

$34.50/hr

S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO ... of employees, customers, contractors, and vendors. 0-3 years exp - supports the design ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

Extremity Care

Facilities Technician

San Diego, CA · On-site

$23.96 - $35.94/hr

Coordinate and assist with external contractors, vendors, and site service providers. * Support ... Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments. * Experience using ...

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Fda Contractor information

What is an FDA contractor?

An FDA contractor is an individual or company that provides goods or services to the U.S. Food and Drug Administration (FDA) under a formal agreement or contract. These contractors may work in a wide range of areas including research, information technology, regulatory consulting, laboratory services, or facility maintenance. FDA contractors are not direct employees of the FDA but play a crucial role in supporting the agency’s mission to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. Their work is often governed by strict regulations and requires compliance with federal standards. Contractors are selected through a competitive procurement process to ensure quality and value.

What are some common challenges faced by FDA Contractors when working with cross-functional teams?

FDA Contractors often collaborate with diverse teams, including regulatory, quality assurance, and clinical staff. One common challenge is aligning different priorities and communication styles while ensuring compliance with regulatory standards and tight project deadlines. Success in this role requires strong organizational skills, adaptability, and proactive communication to keep projects moving smoothly and maintain regulatory integrity. Building rapport and understanding the unique needs of each department can help FDA Contractors effectively bridge gaps and facilitate teamwork.

What is the difference between Fda Contractor vs Fda Auditor?

AspectFda ContractorFda Auditor
Required CredentialsTypically requires knowledge of FDA regulations, compliance, and industry standards; certifications like RAC or CQA are commonRequires similar credentials, often with additional auditing certifications such as CQA or ISO auditor training
Work EnvironmentWorks on projects for FDA-regulated companies, often in labs, manufacturing sites, or officesConducts inspections and audits at facilities, often traveling to various sites
Employer & Industry UsageHired by pharmaceutical, biotech, or medical device companies as external consultantsEmployed by regulatory agencies or contracted to perform compliance audits for FDA oversight

In summary, Fda Contractors focus on supporting companies with compliance projects, while Fda Auditors primarily evaluate and verify adherence to FDA regulations through inspections and audits. Both roles require similar certifications and industry knowledge but differ in their primary functions and work settings.

What are the key skills and qualifications needed to thrive as an FDA Contractor, and why are they important?

To thrive as an FDA Contractor, you need expertise in regulatory compliance, scientific analysis, and project management, often supported by a degree in life sciences or a related field. Familiarity with FDA regulations, electronic submission systems, and specialized software like eCTD or data analysis tools is typically required. Attention to detail, strong communication skills, and adaptability help contractors excel in collaborative and deadline-driven environments. These skills ensure accurate, timely submissions and effective support for FDA regulatory processes.
What are popular job titles related to Fda Contractor jobs in California? For Fda Contractor jobs in California, the most frequently searched job titles are:
What job categories do people searching Fda Contractor jobs in California look for? The top searched job categories for Fda Contractor jobs in California are:
Fda Contractor jobs near you
Infographic showing various Fda Contractor job openings in California as of July 2026, with employment types broken down into 1% Locum Tenens, 72% Full Time, 10% Part Time, and 17% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution.
Senior Product Counsel San Francisco, CA (Hybrid) (971-SLS)

Senior Product Counsel San Francisco, CA (Hybrid) (971-SLS)

Solutus Legal Search

San Francisco, CA • On-site

$216K - $324K/yr

Full-time

Life, Retirement

Posted 24 days ago

Job description

Our client, a publicly traded digital health company leveraging technology and AI to transform care delivery, has exclusively retained Solutus Legal Search to assist the executives in their search for a Senior Product Counsel. This role reports to the Associate General Counsel, Product, and will work closely with other members of the Legal & Compliance team, as well as cross-functional stakeholders across the organization - including access to senior leadership.
In this role, you will serve as a strategic legal partner to the company's Product, R&D, Hardware, Marketing, and Clinical teams as they develop and launch innovative new products and services in the healthcare space. You will be advising on the full spectrum of legal and regulatory issues that arise as the company scales innovative digital health products and services - including an FDA-cleared device, AI-driven care platform, and global offerings. This is a high-impact, individual contributor role for an experienced attorney who can independently navigate complex and ambiguous legal and regulatory landscapes, drive business initiatives forward, and deliver practical, business-enabling legal counsel.
Responsibilities include:
  • Enable product and business initiatives. Collaborate with Product, R&D, Engineering, Marketing, Hardware, Clinical, and other stakeholders throughout the organization to understand, advise on, and drive forward new products, services, technologies, and processes impacting the company's business and members. Serve as a trusted, business-enabling legal partner from brainstorm through launch.
  • Own FDA and medical device legal work. Advise the hardware and product teams on FDA regulatory requirements, including 510(k)/de novo submissions, new indications, device modifications, clinical research, and regulatory inquiries. Manage the legal work related to the company's FDA-cleared medical devices and help avoid enforcement actions.
  • Advise on global expansion. Coordinate with international outside counsel to advise on legal and regulatory requirements across multiple countries and territories. Identify barriers to international product launches, develop creative compliance solutions, and own the global legal workstream for the Product Legal team.
  • Provide guidance on healthcare regulatory and government programs. Advise on legal frameworks applicable to government programs (e.g., Medicare, VA, TRICARE), first dollar coverage (FDC) eligibility, CARES Act implications, and government contracting issues.
  • Support marketing and commercial claims. Review marketing materials, claims, and messaging for legal and regulatory compliance, including FDA promotional requirements, FTC guidelines, and truth-in-advertising standards.
  • Protect the company from unnecessary risk. Proactively identify legal and regulatory issues in company initiatives, think creatively to develop solutions, and collaborate cross-functionally to help the business move forward while managing risk.
  • Develop resources and generate efficiencies. Create and maintain legal resources, guidance documents, FAQs, and trainings to aid internal teams in developing and launching products and services.
  • Stay ahead of the regulatory landscape. Keep up-to-date on legal and regulatory developments relevant to digital health, medical devices, and provision of care and ensure key stakeholders are promptly advised on potential risks and opportunities.

Experience includes:
  • J.D. from an ABA-accredited law school
  • Licensed to practice law in at least one U.S. jurisdiction
  • 5-7 years of experience advising on healthcare legal and regulatory matters, with a strong preference for product counsel experience in the digital health, health tech, or medical device space
  • Demonstrated expertise in FDA regulations and medical device requirements (e.g., 510(k) process, device modifications, promotional compliance)
  • Experience using AI tools to enhance and accelerate deliverables
  • Experience and comfort with working at both an operational and strategic level.
  • Experience advising on international product launches and navigating multi-jurisdictional regulatory frameworks (e.g., EU MDR/IVDR, UK medical device regulations, Health Canada)
  • Familiarity with government contracting requirements (FAR, FEHBAR, TAA) and programs such as Medicare, Medicaid, VA, and TRICARE
  • In-house experience at a technology or digital health company, combined with law firm experience at a nationally recognized firm
  • Strong track record of cross-functional collaboration and ability to communicate complex legal and regulatory concepts in a clear, business-friendly manner
  • Self-starter who thrives working independently; comfortable with ambiguity and shifting priorities

The role offers a competitive compensation package, including a base salary range of $216,000 - $324,000, together with eligibility for equity participation. The company also offers comprehensive benefits, including retirement plans with company match, modern life stipends, and support for family and wellness needs. Total compensation is designed to align with the scope and impact of the position.
Solutus Legal Search is proud to have been exclusively retained to assist our client with this special engagement. Resumes submitted directly to our client will be forwarded to Solutus Legal for evaluation.
Ref. 971-SLS
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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