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Manager Fda Consulting Jobs (NOW HIRING)

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA ... Proficient in using quality management systems and documentation tools. * Ability to provide ...

Heartland Consulting

Project Manager

Washington, DC · Remote

$95K - $125K/yr

Program Manager - FDA Laboratory Documents & Records Management Support Location: Remote / Off-Site, with occasional travel to FDA laboratories Type: Full-Time Salary Range: $95,000 - $125,000 per ...

QSE7

Be Seen First

Sr. Project Manager

Philadelphia, PA · Remote

$80 - $120/hr

About QSE7 Founded in 2016, QSE7 offers innovative and specialized consulting services to FDA-regulated Life Sciences companies. Our areas of focus include program/project management, process ...

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Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a Manager in FDA Consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a Manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

How does a Manager in FDA Consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
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Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in the United States as of July 2026, with employment types broken down into 93% Full Time, 4% Part Time, and 3% Contract. Highlights an 84% Physical, 4% Hybrid, and 12% Remote job distribution.

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • On-site

Contractor

Re-posted 9 days ago

Job description

Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience)
USA Remote (with occasional on-site client visits)
Contract / Self-Employed Basis
About IMSM
IMSM (International Management Systems Marketing) is a global force in ISO consultancy - helping organisations not just achieve certification, but transform the way they operate. We partner with businesses across every sector, elevating performance, boosting compliance and unlocking measurable competitive advantage.
Now part of the Axiom GRC division within the WorkNest group and backed by Inflexion, we bring the reach and resources of a worldwide organisation. With teams spanning the UK, Europe, North America, APAC, Africa and Canada - and a growing network of 85 employees and more than 350 expert contractors enables us to deliver high-quality, results-driven ISO consultancy to clients worldwide.
The Opportunity
We are seeking an experienced FDA Consultant to support regulatory compliance, quality system development, and market readiness activities. The ideal candidate will have deep expertise in FDA regulations alongside hands-on experience implementing and auditing quality systems aligned with ISO 13485 (medical devices) and ISO 22716 (cosmetics GMP).
What You Will Do
  • Provide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections
  • Lead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)
  • Develop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716
  • Conduct gap analyses and internal audits to assess compliance readiness
  • Support preparation for FDA inspections and notified body audits
  • Review and author SOPs, technical documentation, and quality records
  • Advise on risk management processes and product lifecycle compliance
  • Ensure alignment between US FDA regulations and international standards
  • Train internal teams on regulatory requirements and quality standards
  • Liaise with regulatory authorities and external stakeholders as needed and have expertise in management systems and relevant standards

What You Will Bring
  • Proven experience as an FDA consultant or regulatory affairs specialist
  • Strong knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211, 820, and cosmetics regulations)
  • RAC (Regulatory Affairs Certification) or equivalent
  • Demonstrated experience with:
    • ISO 13485 (Medical Devices Quality Management Systems)
    • ISO 22716 (Cosmetic Good Manufacturing Practices)
  • Experience supporting FDA inspections and/or notified body audits
  • Excellent documentation, communication, and analytical skills

Join Our Global Contractor Community
As part of the WorkNest group and the wider Axiom GRC division, you will contribute to a powerful network of more than 800 experts shaping the future of Governance, Risk and Compliance services.
If you are a dedicated ISO professional looking for flexible, rewarding work with a market leading consultancy, we would love to hear from you.
Department Operations Locations USA Remote Remote status Hybrid Employment type Contract

Apply