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Regulatory Affairs Consultant

Dallas, TX

Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...

Nobl Q, LLC.

SAP EWM Consultant

Newark, NJ

SAP EWM Consultant (Pharma) Location: NJ (Onsite) Exp : 14+yrs We are seeking an experienced SAP ... FDA compliance, Serialization, and Track & Trace processes Experience in warehouse operations ...

Syner-G

Consultant II

Framingham, MA

Through our expertise, insight, consulting and management skills, we accelerate breakthrough ... Handle FDA Type A, Type B, Type C and Type D meetings. * Engage in all phases of drug development ...

E-Solutions

Validation Consultant

Raritan, NJ · Hybrid

CSV Consultant - 10+ Years of Exp is Mandatory to have Location: Raritan, NJ (Hybrid - 3 Days ... Experience working in FDA and/or globally regulated GxP environments. * Strong understanding of GxP ...

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Fda Consultant information

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How much do fda consultant jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for fda consultant in the United States is $41.55, according to ZipRecruiter salary data. Most workers in this role earn between $29.33 and $49.52 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an FDA Consultant?

As an FDA Consultant, your days often involve preparing and reviewing regulatory submissions, advising clients on compliance strategies, and staying up-to-date with evolving FDA requirements. You'll work closely with clients in pharmaceutical, medical device, or biotech companies to interpret regulations, conduct gap analyses, and support product development from early stages through post-market compliance. Collaboration with cross-functional teams, such as research, quality assurance, and legal, is common to ensure all processes and documentation meet FDA standards. The work environment is typically a mix of independent analysis and interactive client meetings, offering a balance between technical expertise and strategic consulting.

Is it hard to get hired by the FDA?

Getting hired as an FDA consultant can be competitive due to the specialized knowledge required, such as understanding regulatory guidelines and compliance standards. Candidates often need relevant experience, certifications, and a strong understanding of FDA processes to improve their chances of employment.

How much do FDA consultants make?

FDA consultants typically earn between $80,000 and $150,000 annually, depending on experience, specialization, and location. Senior consultants with extensive regulatory knowledge and certifications can earn higher salaries, often exceeding $200,000. Compensation may also include project-based fees or hourly rates for contract work.

What are the key skills and qualifications needed to thrive in the Fda Consultant position, and why are they important?

To thrive as an FDA Consultant, you need in-depth knowledge of FDA regulations and guidelines, regulatory submission processes, and a relevant science or healthcare background. Familiarity with regulatory databases, document management systems, and certifications like RAC (Regulatory Affairs Certification) are highly valued in this field. Strong analytical skills, attention to detail, and effective communication are key soft skills for advising clients and coordinating with multidisciplinary teams. These skills are essential for ensuring clients achieve compliance, avoid costly delays, and succeed in the highly regulated life sciences industry.

What is an FDA Consultant job?

An FDA Consultant helps businesses navigate FDA regulations to ensure compliance with federal laws related to drugs, medical devices, food, and other regulated products. They provide expert guidance on submissions, approvals, inspections, and regulatory strategies. Their role is crucial for companies seeking to bring products to market while meeting all legal requirements.

What does an FDA consultant do?

An FDA consultant advises pharmaceutical, biotech, medical device, or food companies on compliance with U.S. Food and Drug Administration regulations. They assist with product development, regulatory submissions, audits, and ensuring adherence to safety and quality standards, often requiring knowledge of FDA guidelines and relevant certifications. Their role helps companies navigate complex regulatory processes to bring products to market legally and efficiently.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, with salaries often exceeding $200,000 annually. Other high-paying positions include senior scientists, medical officers, and regulatory directors, especially those with advanced degrees and extensive experience in regulatory affairs or public health.
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Fda Consultant jobs near you
Infographic showing various Fda Consultant job openings in the United States as of June 2026, with employment types broken down into 94% Full Time, 5% Part Time, and 1% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $86,430 per year, or $41.6 per hour.

Senior Regulatory Affairs Specialist -FDA Medical

Wacker Chemical Corporation

Ann Arbor, MI • Hybrid

Other

Medical, Dental, Vision, Retirement, PTO

Posted 12 days ago

Wacker Chemical Corporation rating

9.1

Company rating: 9.1 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

4th of 90 rated chemical manufacturers

Job description

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
To strengthen our team in Ann Arbor,
we are looking for you as a(n) Senior Regulatory Affairs Specialist -FDA Medical.

Senior Regulatory Affairs Specialist-FDA Medical

  • Responsible for managing Wacker Chemical Corporation's corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
  • Responsible for refining Wacker's corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications.
  • Evaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
  • Preparsand submitsforms and applications for Wacker FDA Drug and Device Master Files. Prepare portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation and preparing and submitting Medical Device Master File (MAF) packages and updates.
  • Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing.
  • Awareness of drug facility registration requirements would be useful. For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products.
  • Recognition of the differences between US and Canadian regulations. Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent
  • Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
  • Will interpretFDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG). Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process.

Requirements:

  • Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.
  • 7+ years of experience preferred.
  • Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
  • Strong leadership, interpersonal and problem-solving skills.
  • Experience working in cross-functional teams.
  • Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
  • Experience in polymer chemistry is preferred.
What do we offer?
WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.
WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.
  • Compensation and Incentive plans
  • Medical, Dental, and Vision Insurance effective day 1
  • Paid Time Off in addition to personal days and holidays
  • Paid parental leave
  • Wellbeing fund
  • Flexible hybrid work arrangements
  • 401(k) with company match
  • Education Assistance Program
  • Career development and advancement opportunities
  • Support for Community Involvement
We are looking forward to your online application at www.wacker.com.
Reference Code:31073
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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).
WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.

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