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Fda Officer Jobs in California (NOW HIRING)

ExThera Medical

Chief Operating Officer

Martinez, CA · On-site

... Officer (COO) with a strong quality background to lead and scale our operations. This role is ... Establish and maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485 ...

Voxelcloud

Chief Technology Officer

Los Angeles, CA · On-site

... Officer as a key member of the senior management team to continue growing the company's tech group ... Lead technical aspects of VoxelCloud's products' clinical trials, FDA clearance process and ...

Voxelcloud

Chief Technology Officer

Los Angeles, CA · On-site

... Officer as a key member of the senior management team to continue growing the company's tech group ... Lead technical aspects of VoxelCloud's products' clinical trials, FDA clearance process and ...

Caltech

Laser Safety Officer (LSO)

Pasadena, CA · On-site

$139K - $160K/yr

... FDA) regulations relating to laser use (21 CFR 1040.10 and 1040.11). * Strong communication ... Certified Laser Safety Officer (CLSO) credential through the Board of Laser Safety. * Experience in ...

insitro

Chief Medical Officer

South San Francisco, CA · On-site

We are seeking an innovative, highly quantitative, and data-driven Chief Medical Officer (CMO) to ... Lead successful interactions and submissions with major global regulatory bodies (e.g., FDA, EMA ...

Sapta Global Inc

Tester

Signal Hill, CA · On-site

Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily ...

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Fda Officer information

What is an FDA officer?

FDA Officers are professionals who work for the U.S. Food and Drug Administration (FDA), a federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and other products. Their duties typically include inspecting facilities, evaluating products for compliance with regulations, investigating violations, and ensuring that manufacturers follow safety standards. FDA Officers play a key role in safeguarding the nation’s health by enforcing laws and overseeing the approval process for new products before they reach the market.

What are the key skills and qualifications needed to thrive as an FDA officer?

To thrive as an FDA Officer, you typically need a background in life sciences, pharmacy, or public health, with relevant degrees and/or regulatory certifications. Familiarity with regulatory submission systems, compliance databases, and quality management tools is crucial. Strong analytical thinking, attention to detail, and effective communication skills help you interpret regulations and collaborate with stakeholders. These abilities are vital to ensure public safety, regulatory compliance, and the integrity of food and drug oversight.

What are some common challenges faced by FDA officers in ensuring regulatory compliance within organizations?

FDA Officers often navigate complex and evolving regulations while ensuring that their organization remains fully compliant with federal standards. A common challenge is staying updated on frequent regulatory changes and accurately interpreting how these changes impact internal processes. Additionally, FDA Officers must effectively communicate compliance requirements across different departments and foster collaboration to implement necessary changes. Balancing strict regulatory demands with business objectives and timelines can also require strong problem-solving and negotiation skills.

What is the difference between Fda Officer vs Fda Investigator?

AspectFda OfficerFda Investigator
Required CredentialsBachelor's degree, often in life sciences or related fields; sometimes advanced degreesBachelor's or higher in sciences; specialized training in investigations
Work EnvironmentOffice-based, regulatory compliance, policy enforcementFieldwork, inspections, investigations at facilities or sites
Employer & Industry UsageU.S. Food and Drug Administration, regulatory agenciesU.S. Food and Drug Administration, enforcement division
Common Search & ComparisonRegulatory roles, compliance, policyInspections, enforcement, compliance investigations

Fda Officers primarily focus on regulatory compliance, policy enforcement, and overseeing food and drug safety from an office setting. In contrast, Fda Investigators conduct field inspections and investigations at facilities to ensure compliance. Both roles require similar educational backgrounds but differ in work environment and daily responsibilities.

How to become an FDA officer?

To become an FDA officer, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences, along with experience in regulatory or scientific roles. Many positions require passing the U.S. Office of Personnel Management's civil service exam and obtaining specialized training or certifications related to food and drug regulation. Strong analytical skills, attention to detail, and knowledge of FDA regulations are essential for success in this role.

What are popular job titles related to Fda Officer jobs in California?

For Fda Officer jobs in California, the most frequently searched job titles are:

What job categories do people searching Fda Officer jobs in California look for?

The top searched job categories for Fda Officer jobs in California are:

What cities in California are hiring for Fda Officer jobs?

Cities in California with the most Fda Officer job openings:

Fda Officer jobs near you

Chief Operating Officer

ExThera Medical

Martinez, CA • On-site

Full-time

Re-posted 6 days ago

Job description


About ExThera Medical
ExThera Medical is an innovative medical device company dedicated to advancing novel blood purification technologies that address critical healthcare challenges, including infectious diseases and sepsis. Our mission is to improve patient outcomes through cutting-edge science, strong clinical partnerships, and operational excellence.
Position Overview
ExThera Medical is seeking a strategic and execution-oriented Chief Operating Officer (COO) with a strong quality background to lead and scale our operations. This role is critical to ensuring our products meet the highest standards of safety, compliance, and performance while driving operational efficiency and supporting company growth.
The ideal candidate brings deep experience in materials-intensive medical devices and/or biotech, with a proven ability to integrate quality systems, manufacturing, and operational strategy in a fast-paced, regulated environment.
This position requires a local candidate based in or near Martinez, CA, with the ability to work on-site five (5) days per week.
Key Responsibilities
  • Lead day-to-day operations across manufacturing, supply chain, and quality functions
  • Establish and maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements
  • Partner with executive leadership to define and execute company strategy and operational roadmap
  • Drive operational scalability to support clinical and commercial growth
  • Oversee manufacturing processes, vendor management, and supply chain optimization
  • Ensure inspection readiness and lead interactions with regulatory agencies (e.g., FDA audits)
  • Build, mentor, and lead high-performing cross-functional teams
  • Implement KPIs and operational metrics to improve efficiency, quality, and cost-effectiveness
  • Support product development and commercialization efforts with a strong quality and compliance lens

Qualifications
  • Bachelor’s degree in Chemical Engineering (preferred)  or Chemistry required; advanced degree (MBA, MS, or equivalent) preferred
  • 15+ years of leadership experience in medical device, biotech, or life sciences
  • Demonstrated success in an operations leadership role (VP Operations, COO, or equivalent)
  • Deep expertise in quality systems, regulatory compliance, and FDA/ISO standards
  • Experience scaling operations in a growth-stage or emerging company environment
  • Strong knowledge of GMP, QSR, ISO 13485, and risk management frameworks
  • Proven ability to lead through complexity and drive cross-functional alignment
  • Excellent communication and executive leadership skills
  • Preferred Experience
  • Background in blood purification, critical care, or extracorporeal therapies
  • Experience supporting clinical trials and commercialization of Class II/III devices
  • Track record of successful regulatory inspections and product approvals

Why Join ExThera Medical
  • Opportunity to shape the future of a high-impact, life-saving technology
  • Collaborative and mission-driven culture
  • Visibility and influence at the executive leadership level
  • Competitive compensation, equity, and benefits package

Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $180,295 and $225,856. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
 

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