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Fda Officer Jobs (NOW HIRING)

BluZinc

COO Chief Operating Officer

Austin, TX · On-site +1

$200K - $275K/yr

... FDA and customer satisfaction * Strong budget formulation and management experience to ensure ... the CFO * M&A, Capital Investments and Fundraising experience * Excellent tenure and career ...

Legend Biotech USA, Inc.

Work closely with Regulatory Affairs to interact with agencies (FDA, NMPA, EMA) and provide ... Previous experience serving in a CMO or senior medical leadership role within a commercial-stage ...

Marylandconnect

Job Posting: JR101562 Research and Integrity Officer (Contingent II - Grant Funded) (Open ... Ensure alignment with federal regulations (45 CFR 46, FDA, USDA, PHS, 42 CFR 93, etc.). * Review ...

Epicur

Lead Compliance Officer

Mount Laurel, NJ · On-site

$75K/yr

Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B ... The Lead Compliance Officer acts as a key advisor and leader in ensuring the organization ...

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Fda Officer information

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.

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

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 FDA Officers and what do they do?

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.
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Infographic showing various Fda Officer job openings in the United States as of May 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Medical Officer - Neurology SME

Tunnell Government Services

Bethesda, MD

Other

Posted 23 days ago

Job description

FDA CDRH - Medical Officer (Neurology) SME Position Description 

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH's projects.

Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and neurology, as relevant to medical devices used to diagnose, treat, and monitor neurological conditions, such as Parkinson's disease, epilepsy, and traumatic brain injuries.

Requirements and Qualifications

  • The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
  • In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
  • At least seven (7) years of relevant clinical experience
  • Certification from a U.S. relevant specialty board organization, e.g., American Board of Psychiatry and Neurology, etc.
  • Thorough understanding of current clinical practices in neurology, including diagnosis and treatment, and current/emerging trends in practice.
  • Preferred experience with, or interest in neurological medical devices (e.g., deep brain stimulators, neurostimulators, neurointerventional devices, or exoskeletons for rehabilitation, etc.), to include knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.
  • Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 882 -- Neurological Devices), and guidances is preferred.
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.

This position is 100% telework. 

Must be a US Citizen or full Green Card holder.

Apply