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Fda Officer Jobs (NOW HIRING)

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance. * In-depth knowledge of quality systems, regulatory requirements (21 CFR ...

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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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What job categories do people searching Fda Officer jobs look for? The top searched job categories for Fda Officer jobs are:
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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.

FDA Technical Consultant

Alston

Washington, DC • On-site, Remote

Full-time

Posted 8 days ago

Job description

THE FIRM

As a leading international law firm, we are dedicated to excellence through impactful communication, collaboration, and community involvement. Our company culture has earned us one of the "100 Best Companies to Work For" for 27 consecutive years. This honor, along with many others, highlights our commitment to innovation and professional development. At Alston & Bird LLP, our foundation is made of trust, reliability, and compassion.

JOB DESCRIPTION

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience as an FDA investigator or a senior role in global quality, to assist our FDA team in responding to FDA inspections at pharmaceutical and medical device manufacturing sites. This role offers flexibility to work hybrid or a fully remote arrangement. Candidates should be self-starters, highly organized, and team players. Extended hours and regular domestic and international travel are often needed to meet client deadlines.

Key Responsibilities

  • Assist attorneys in supporting manufacturing clients on issues related to Current Good Manufacturing Processes (CGMP) compliance

  • Prepare clients for inspections, provide inspection support (remote and on-site)

  • Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other enforcement actions

  • Extensive knowledge and experience related to quality systems, investigations, Corrective & Preventative Actions (CAPAs), contamination control, cleaning validation, and data integrity are essential for this role

  • Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory, quality, manufacturing, and executive leadership teams

  • Draft memos regarding the status of projects

  • Maintain current and accurate daily time record

  • Perform special projects as assigned

SKILLS NEEDED TO BE SUCCESSFUL

  • Regular travel within the United States and Internationally. Regular travel 1-2 weeks a month with flexibility for more.

  • Ability to organize and prioritize numerous tasks and complete them under time constraints.

  • Interpersonal skills necessary in order to communicate and follow instructions effectively from a diverse group of clients, attorneys and staff and provide information with ordinary courtesy and tact.

  • Work typically requires more than 40 hours per week to perform the essential duties of the position; may require irregular hours.

  • Ability to travel to private and public buildings, domestically and internationally, via private or public conveyance to assist attorney in attending to client needs on legal matters.

EDUCATION & EXPERIENCE

  • Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related field.

  • FDA experience required.

  • Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance.

  • In-depth knowledge of quality systems, regulatory requirements (21 CFR Parts 210, 211 and related guidance), quality management systems (QMS), and ISO standards.

  • Strong analytical skills with a focus on root cause analysis and problem-solving.

  • Excellent written and verbal communication skills, enabling effective interaction with various stakeholders.

  • Proficient in using quality management systems and documentation tools.

  • Ability to provide exceptional client service and manage multiple engagements in a fast-paced environment.

  • Willingness to frequently travel to international and domestic client sites to support inspections, audit, and remediation activities.

The salary range for this position in Washington D.C. is $200,000-$250,000 and represents the firm's good faith minimum and maximum range for this role at the time of posting. The actual salary offered will be dependent on various factors, including but not limited to, the candidate's experience, education, relevant certifications, geographic location, market demands, and specific business needs. Generally, candidates are considered for the higher end of the salary range when they bring the requisite level of experience and expertise to the role.

EQUAL OPPORTUNITY EMPLOYER

Alston & Bird LLP is an Equal Opportunity Employer does not discriminate on the bases of any status protected under federal, state, or local law. Applicants will be considered regardless of their sex, race, age, religion, color, national origin, ancestry, physical disability, mental disability, medical condition (associated with cancer, a history of cancer, or genetic characteristics), HIV/AIDS status, genetic information, marital status, sexual orientation, gender, gender identity, gender expression, military and veteran status, or other protected category under the law on the basis of race, color, religion, sex, age, sexual orientation, gender identity and/or expression, national origin, veteran status or disability in relation to our recruiting, hiring, and promoting practices.

The statements contained in this position description are not necessarily all-inclusive, additional duties and responsibilities may be assigned, and requirements may vary from time to time.

Professional business references and a background screening will be required for all final applicants selected for a position.

If you need assistance or an accommodation due to a disability you may contactdonavan.mclean@alston.com.

Alston & Bird is not currently accepting resumes from agencies for this position. If you are a recruiter, search firm, or employment agency, you will not be compensated in any way for your referral of a candidate even if Alston & Bird hires the candidate.

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