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Manager Fda Consulting Jobs in Ohio (NOW HIRING)

RSM

SAP Transformation Risk Manager

Columbus, OH · On-site

TheERP Risk and Automation Services (ERAS) Consulting practice,assistswith various consulting ... Familiarity with SOX, FDA, data privacy, ICFR, and other audit standards * Bachelor's or Master ...

Amgen SA

Training & Development Manager

New Albany, OH · On-site

$90 - $130/hr

Experience in performance consulting and needs analysis * Experience using ADDIE or other ... A general understanding of working in a regulated environment (e.g., FDA, OSHA) * Ability to work ...

New

Manpower Engineering

Production Manager

Columbus, OH · On-site

$100K - $120K/yr

Strong knowledge of food manufacturing regulations (FDA/USDA, OSHA, EPA) preferred. * Proven ... Upon completion of waiting period, consultants are eligible for: * Medical and Prescription Drug ...

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Manager Fda Consulting information

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.

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.

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 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.

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For Manager Fda Consulting jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Manager Fda Consulting jobs in Ohio look for?

The top searched job categories for Manager Fda Consulting jobs in Ohio are:

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Cities in Ohio with the most Manager Fda Consulting job openings:

Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Ohio as of August 2026, with employment types broken down into 81% Full Time, 15% Part Time, and 4% Contract. Highlights an 78% Physical, 2% Hybrid, and 20% Remote job distribution.

Senior Director of Regulatory Affairs

Cleveland Diagnostics, Inc.

Cleveland, OH • On-site

$125K - $225K/yr

Full-time

Dental, Vision, Life, Retirement, PTO

Posted 24 days ago

Job description

Job Title: Senior Director of Regulatory Affairs
Reports to: Chief Medical Officer
Job Overview
The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics' in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. This role will lead the development, execution, and maintenance of global regulatory strategies across the full product lifecycle, including pre-market submissions, post-market obligations, regulatory agency interactions, and ongoing compliance with applicable U.S. and international regulatory requirements.
The Senior Director will serve as a regulatory leader for FDA-regulated IVD products, including PMA, PMA supplement, 510(k), amendment, annual report, and post-approval submission activities, as well as international regulatory documentation, including IVDR Technical Documentation and other jurisdictional requirements where applicable. This position requires strong strategic judgment, integrity, deep knowledge of IVD and other regulatory pathways, excellent technical writing and review capabilities, and the ability to lead cross-functional teams through complex regulatory programs.
The role is expected to operate at both a strategic and hands-on level, providing executive-level regulatory guidance while ensuring high-quality execution of submissions, regulatory documentation, and compliance activities.
Essential Duties & Responsibilities
Regulatory Strategy and Leadership
  • Lead the development and execution of regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
  • Serve as the company's senior regulatory subject matter expert for U.S. FDA and applicable international regulatory requirements related to IVD and LDT products.
  • Provide strategic regulatory guidance to executive leadership, product development teams, clinical operations, medical affairs, quality assurance, manufacturing, legal/compliance, and commercial stakeholders.
  • Assess regulatory pathways, submission requirements, approval risks, and post-market obligations for new products, expanded indications, product modifications, and lifecycle management activities.
  • Translate regulatory requirements into actionable development, clinical, medical affairs, quality, manufacturing, and submission plans.
  • Anticipate regulatory risks and develop mitigation strategies to support timely product development, approval, launch, and post-market maintenance.
  • Lead interactions when appropriate with outside legal, regulatory, and statistical consultants.

Regulatory Submissions and Agency Interactions
  • Lead the planning, preparation, review, submission, and maintenance of regulatory submissions and related documentation, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, FDA correspondence, and international regulatory dossiers.
  • Oversee preparation and maintenance of IVDR Technical Documentation and other international regulatory documentation, as applicable.
  • Lead or support interactions with FDA, Notified Bodies, and other regulatory authorities, including meeting requests, pre-submission activities, responses to questions, deficiency responses, and post-approval communications.
  • Ensure regulatory submissions are accurate, complete, scientifically sound, strategically positioned, and submitted in accordance with applicable timelines and requirements.
  • Provide senior-level review of technical, clinical, analytical, manufacturing, labeling, and quality documentation for regulatory consistency and compliance.

Product Lifecycle and Change Management
  • Lead regulatory assessment of product development activities, design changes, manufacturing changes, process changes, labeling changes, and clinical or analytical updates.
  • Determine appropriate regulatory reporting or submission requirements for product and process changes.
  • Partner with Quality Assurance, Manufacturing, IVD Test Development, Clinical Operations, and other functions to ensure changes are properly assessed, documented, and implemented in compliance with regulatory requirements.
  • Oversee maintenance of product approvals, listings, registrations, supplements, amendments, post-approval reports, and related regulatory records on a domestic and international basis.

Post-Market Regulatory Compliance
  • Provide leadership for post-market regulatory activities, including post-market surveillance, vigilance reporting, adverse event assessment, field action support, annual reporting, and regulatory record maintenance.
  • Ensure post-market regulatory obligations are identified, tracked, and fulfilled in accordance with FDA, IVDR, and other applicable requirements.
  • Support quality system activities related to complaints, CAPAs, nonconformances, audits, inspections, and regulatory reporting decisions.
  • Monitor evolving regulatory requirements, guidance documents, standards, and enforcement trends and communicate relevant implications to internal stakeholders.

Cross-Functional Collaboration and Organizational Leadership
  • Lead cross-functional regulatory planning and execution with Clinical Operations, Legal and Compliance, IVD Test Development, Quality, Manufacturing, Commercial, Medical Affairs, and external consultants.
  • Provide regulatory leadership for product development teams, clinical study teams, design control activities, and launch readiness planning.
  • Build, manage, and mentor regulatory affairs personnel, consultants, and vendors as needed.
  • Establish clear regulatory roles, timelines, deliverables, and accountability across internal and external teams.
  • Promote a culture of regulatory excellence, scientific rigor, documentation discipline, and compliance.

Regulatory Systems, Policies, and Documentation
  • Lead the development, implementation, and maintenance of regulatory policies, procedures, templates, regulatory intelligence processes, and submission standards.
  • Ensure regulatory documentation systems support accuracy, traceability, version control, and inspection readiness.
  • Oversee regulatory document management practices for large, complex technical files and submission packages.
  • Support continuous improvement of regulatory processes, tools, and templates to improve quality, efficiency, and compliance.

Other Duties
  • Represent Regulatory Affairs in internal leadership meetings, project governance discussions, audits, inspections, and external regulatory engagements.
  • Support business development, partnership, investor, or commercial activities by providing regulatory input as requested.
  • Participate as an integral member of the Cleveland Diagnostics Senior Leadership Team (SLT)
  • Perform other duties as assigned.

Qualifications/Requirements
  • Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
  • Significant experience with FDA-regulated IVD products required.
  • Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
  • Experience with blood-based diagnostics, oncology diagnostics, laboratory-developed tests, companion diagnostics, and early cancer detection products preferred.
  • Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions preferred.
  • Prior experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
  • Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred.
  • Experience supporting FDA inspections, audits, quality system activities, complaint evaluations, vigilance reporting, or post-market surveillance preferred.

Knowledge, Skills, and Abilities
  • Deep working knowledge of applicable regulatory frameworks, including FDA medical device and IVD regulations, PMA requirements, 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance documents.
  • Strong strategic judgment and ability to advise executive leadership on regulatory risks, options, timelines, and business implications.
  • Excellent technical writing, editing, and regulatory submission review skills.
  • Ability to critically assess scientific, clinical, analytical, quality, manufacturing, and technical documentation.
  • Strong leadership, communication, negotiation, and cross-functional collaboration skills.
  • Ability to manage multiple complex regulatory programs, competing priorities, and time-sensitive deliverables, and regulatory affairs program budgets/KPIs
  • Exceptional attention to detail and strong document management, version control, and regulatory records discipline.
  • Advanced proficiency with Microsoft Word & Excel, and complex document formatting, including templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
  • Ability to operate effectively in a growing, fast-paced organization with hands-on involvement as needed.

Physical Requirements
  • Offices are reachable by elevator; must be able to climb stairs in the event elevator access is unavailable. General office and HVAC noise & fluorescent and/or LED lighting
  • Ability to sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
  • May occasionally enter laboratory or manufacturing areas and may be exposed to hazardous chemicals, biohazards, or related controlled environments, subject to applicable safety procedures.

Other Requirements
  • This may be a hybrid position however Cleveland area candidates are preferred
  • Occasional travel may be required for regulatory meetings, audits, inspections, conferences, partner meetings, or other business needs.
  • Must be able to maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.

Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics.
We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.
Cleveland Diagnostics offers an extremely robust benefits package which includes:
  • 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
  • 100% Employer-paid Dental & Vision for entire family
  • No cost for employee coverage for Group Term Life, Short & Long Term Disability
  • 4% retirement contribution Employer match
  • Incentive Performance Plan & Stock Option Program & Commission program
  • Generous PTO plan & holiday program
  • Flexible work schedule & lucrative employee referral program
  • Salary may vary by work state/geographical region/territory
  • Easy to get to office location with newly built-out office space
  • Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
Pay Range: $125,000 - $225,000 per year

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