1

Fda Jobs in Georgia (NOW HIRING)

Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards. * Provide regulatory support to product development teams by offering guidance on applicable ...

Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times. * Address compliance issues and manage CAPAs effectively. * Promote accountability, data ...

Quality Engineer - Sr

Alpharetta, GA · On-site

$84K - $114K/yr

This role ensures compliance with applicable regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 803/806/820, ISO 13485, MDSAP) by preparing Post-Market Surveillance Reports (PMSR), Periodic ...

Quality Engineer - Sr

Alpharetta, GA · On-site

$84K - $114K/yr

This role ensures compliance with applicable regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 803/806/820, ISO 13485, MDSAP) by preparing Post-Market Surveillance Reports (PMSR), Periodic ...

The LIMS SME/Business Analyst will provide support for an enterprise StarLIMS implementation for the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA). The duties for this ...

Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times. * Address compliance issues and manage CAPAs effectively. * Promote accountability, data ...

Head of REMS US, Atlanta, GA

Atlanta, GA · On-site

$184K - $242K/yr

Lead REMS regulatory submissions, FDA communications, and program modifications. * Ensure inspection readiness, risk management, compliance monitoring, and continuous improvement. * Manage program ...

Head of REMS US, Atlanta, GA

Atlanta, GA · On-site

$184K - $242K/yr

Lead REMS regulatory submissions, FDA communications, and program modifications. * Ensure inspection readiness, risk management, compliance monitoring, and continuous improvement. * Manage program ...

Showing results 21-40

Fda information

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

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

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.

What are the most commonly searched types of Fda jobs in Georgia?

The most popular types of Fda jobs in Georgia are:

What cities in Georgia are hiring for Fda jobs?

Cities in Georgia with the most Fda job openings:

Infographic showing various Fda job openings in Georgia as of August 2026, with employment types broken down into 95% Full Time, and 5% Part Time. Highlights an 100% In-person job distribution.

Senior Business Development Leader

Precoh, LLC.

Atlanta, GA • On-site

$120 - $160/hr

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted yesterday


Job description

Business Development Founding Team Atlanta-preferred · Remote (US) Full-time

Senior Business Development Leader

Healthcare AI / Regulated Markets — Reports to Founder / CEO

About Precoh

Precoh turns AI regulation into real-world deployment. Our platform, RegOS, transforms fragmented regulatory requirements (FDA SaMD, EU MDR, IMDRF) into structured, executable, and auditable workflows — so clinical AI can be evaluated, approved, and scaled with confidence.

Alongside RegOS, our advisory practice runs sandbox-readiness sprints, regulated-AI experiment design, and implementation pilots for three buyer types:

  • Regulators and sandbox operators running consistent, reproducible evaluations across AI submissions.
  • Health systems evaluating third-party AI before procurement and across the post-market lifecycle.
  • AI and MedTech companies running pre-submission evaluations before FDA or EU MDR filing.

We are early, founder-led, and revenue-generating. This is a foundational commercial role on our team.

Why this role exists

The regulatory-AI market is forming in real time, and the buyers — Chief AI Officers, CMIOs, regulatory affairs leaders, sandbox operators — are sophisticated, technical, and skeptical of generic GTM motions. We are looking for a commercial leader who can sit across the table from a Chief AI Officer at a multi-hospital system, a regulator running a SaMD sandbox, and a clinical‑AI startup preparing for submission — and translate Precoh's regulatory infrastructure into structured pilots, signed engagements, and a repeatable pipeline.

This is a build-the-engine role. You will own the commercial motion end-to-end and grow a team underneath you.

What you will own
  • Stand up Precoh's commercial operating system: ICP definition, target-account list, CRM, outbound, deal stages, and forecast.
  • Codify Precoh's service offerings into clean packages, scoping templates, and pricing playbooks.
  • Run discovery with qualified buyers and produce written buyer‑insight memos that sharpen positioning, packaging, and pricing.
  • Own a self-sourced pipeline and convert it across health systems, regulators / sandbox operators, and AI/MedTech vendors.
  • Lead complex, multi‑stakeholder pursuits across Chief AI Officers, regulatory affairs, IT/security, procurement, and clinical leadership.
  • Land and shape design‑partner engagements with regulators and sandbox operators.
  • Partner with the founder on category creation: thought‑leadership, conference presence (HIMSS, RSNA, AdvaMed, FDA workshops), and analyst briefings.
  • Hire and ramp the next commercial roles (BD/AE and a sales engineer / regulatory solutions lead) and build out a partner channel with QMS vendors, CROs, AI assurance firms, and advisory practices.
What you will do day‑to‑day
  • Run technical discovery — confidently discuss FDA SaMD risk classes, 510(k) vs. De Novo, EU MDR Class IIa/IIb, predetermined change control plans (PCCPs), Good Machine Learning Practice (GMLP), bias and fairness evaluation, post‑market surveillance, and AI assurance frameworks (NIST AI RMF, ISO/IEC 42001, IMDRF).
  • Translate buyer pain into RegOS evaluation scope, evidence packages, and decision artifacts.
  • Build proposals, MSAs, and SOWs alongside the founder; negotiate pricing, success criteria, and data‑use terms.
  • Maintain a live point of view on the competitive landscape — AI assurance startups, QMS vendors, advisory practices, and academic evaluation labs.
  • Run the deal desk: forecast accuracy, pipeline hygiene, and weekly commercial reviews.
  • Produce written artifacts — buyer memos, deal reviews, win/loss analyses — at a level that ships externally.
Must‑have qualifications
  • 8+ years in business development, commercial strategy, or GTM leadership, with at least 3 years selling a technical product or advisory service into healthcare, life sciences, or another regulated industry.
  • Demonstrated wins with one or more of: US health systems / academic medical centers, regulators or sandbox operators, AI/MedTech companies, or pharma R&D and clinical operations.
  • Working fluency in regulated‑AI vocabulary: SaMD, FDA premarket pathways, EU MDR, IMDRF, clinical validation, model risk management, AI governance, bias/fairness, post‑market monitoring.
  • Track record of large, complex enterprise deals with multi‑stakeholder cycles spanning procurement, security, legal, and clinical.
  • Founder‑mode operator: you have built a pipeline from a blank CRM, written your own decks, and run your own demos.
  • Exceptional writing. You can produce a buyer memo, a 1‑pager, and an investor‑grade narrative without hand‑holding.
  • Atlanta‑based or willing to spend material time here. Remote considered for exceptional candidates.
Strongly preferred
  • Prior experience at a healthcare‑AI, RegTech, AI‑governance, clinical‑evidence, or QMS company.
  • Direct relationships with Chief AI Officers, CMIOs, VPs of Regulatory Affairs at health systems, or program leads at FDA, state sandboxes, NHS, or Health Canada.
  • Experience designing and selling pilot programs and design‑partner agreements rather than transactional SaaS.
  • Technical background — clinical, engineering, data science, biostatistics, regulatory affairs, or law (JD/MPH/RAC welcome).
  • Exposure to model risk management or AI assurance in another regulated industry (financial services, defense) translatable to healthcare.
Nice to have
  • Published thought leadership (substack, conference talks, peer‑reviewed work) on clinical AI, regulation, or AI governance.
  • Experience hiring and managing a small commercial team.
  • Existing network across HIMSS, RSNA, AdvaMed, AMIA, CHAI, or major academic medical centers.
  • Competitive base salary calibrated to experience and location.
  • Performance‑based variable compensation appropriate for a founding commercial hire.
  • Meaningful founding‑team equity grant.
  • Health, dental, vision; 401(k); flexible PTO; conference and learning budget.

Precoh is an equal opportunity employer. We welcome applicants from all backgrounds and explicitly encourage applications from clinicians, regulators, and operators considering a move into commercial roles.

#J-18808-Ljbffr