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Fda Reviewer Jobs in Tennessee (NOW HIRING)

Revance

Regulatory Device Specialist

Johnson City, TN · On-site

$65K - $73K/yr

FDA, Health Canada, EU, APAC, Middle East). * Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product ...

Revance

Regulatory Device Specialist

Johnson City, TN · Remote

$65K - $73K/yr

FDA, Health Canada, EU, APAC, Middle East). * Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product ...

Socket.dev

Senior Legal Counsel

Nashville, TN · On-site

$150 - $230/hr

Review advertising, promotional, and marketing materials for compliance with healthcare laws, FDA requirements, substantiation standards, and company policies. * Develop and maintain contract ...

STI

Grants Coordinator

Nashville, TN · On-site

$47K - $65K/yr

Review monthly expenditure reports, calculate projections, and meet with the Lab Grants Coordinator ... Attend CDC/FDA/HHS webinars and calls to get programmatic information * Grant coordination on non ...

NICE-PAK PRODUCTS LLC

ENGINEER QUALITY (5122)

Smyrna, TN · On-site

$67K - $86K/yr

... FDA regulations. Responsible for maintaining Process Variance Reports and Annual Product Reviews for the manufacturing and distribution locations. Ensure budget and schedule remain complaint with ...

VIVOS HOLDINGS

ENGINEER QUALITY

Smyrna, TN

$67K - $86K/yr

... FDA regulations. Responsible for maintaining Process Variance Reports and Annual Product Reviews for the manufacturing and distribution locations. Ensure budget and schedule remain complaint with ...

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How much do fda reviewer jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for fda reviewer in Tennessee is $27.12, according to ZipRecruiter salary data. Most workers in this role earn between $20.53 and $33.17 per hour, depending on experience, location, and employer.

What is an FDA reviewer?

FDA Reviewers are professionals who evaluate and assess applications for the approval of drugs, medical devices, biologics, and other products regulated by the U.S. Food and Drug Administration (FDA). They review scientific data, clinical trial results, and manufacturing information to ensure the safety, efficacy, and quality of products before they reach the market. FDA Reviewers work within specialized teams and often collaborate with scientists, physicians, and regulatory experts. Their work helps protect public health by ensuring that only safe and effective products are available to consumers.

What skills and qualifications are needed to be an FDA reviewer?

To thrive as an FDA Reviewer, you need a strong background in scientific research, regulatory affairs, and a relevant advanced degree such as pharmacy, biology, chemistry, or medicine. Familiarity with regulatory submission systems, data analysis tools, and knowledge of FDA guidelines and Good Clinical Practice (GCP) is critical. Attention to detail, effective communication, and critical thinking are essential soft skills for evaluating complex data and collaborating with stakeholders. These skills ensure accurate and thorough assessments of products, supporting public health and regulatory compliance.

What are common challenges faced by FDA reviewers during the product evaluation process?

FDA Reviewers often face tight deadlines and must carefully balance thorough scientific evaluation with regulatory timelines. Reviewing large volumes of complex data, ensuring compliance with evolving regulations, and collaborating with multidisciplinary teams can be demanding. Additionally, reviewers must stay updated on new scientific developments and technologies, which requires continual learning and adaptability. These challenges make strong organizational skills and effective communication crucial for success in this role.

What is the difference between Fda Reviewer vs Fda Investigator?

AspectFda ReviewerFda Investigator
Primary RoleReview and evaluate regulatory submissions for safety, efficacy, and compliance of medical productsConduct inspections and investigations to ensure compliance with FDA regulations
Work EnvironmentOffice-based, reviewing documents and dataFieldwork, inspecting facilities and conducting interviews
Required CredentialsTypically a background in life sciences, healthcare, or related fields; often requires a degree and regulatory knowledgeSimilar credentials; often a degree in sciences, with training in inspection procedures

While both roles work within the FDA and require scientific knowledge, Fda Reviewers focus on evaluating submissions for approval, whereas Fda Investigators conduct on-site inspections to verify compliance. Both positions are essential for ensuring the safety and efficacy of medical products, but they differ in daily tasks and work settings.

How much do FDA reviewers make?

FDA reviewers typically earn a salary ranging from $70,000 to $130,000 annually, depending on experience, education, and location. They often hold degrees in science or healthcare and work in regulatory environments that require attention to detail and knowledge of FDA regulations.

What are popular job titles related to Fda Reviewer jobs in Tennessee?

For Fda Reviewer jobs in Tennessee, the most frequently searched job titles are:

What job categories do people searching Fda Reviewer jobs in Tennessee look for?

The top searched job categories for Fda Reviewer jobs in Tennessee are:

What cities in Tennessee are hiring for Fda Reviewer jobs?

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Fda Reviewer jobs near you
Infographic showing various Fda Reviewer job openings in Tennessee as of August 2026, with employment types broken down into 80% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $56,417 per year, or $27.1 per hour.

Regulatory Device Specialist

Johnson City, TN • On-site

Revance
Manufacturing • 201 - 500 employees
Learn more about Revanceexternal

$65K - $73K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 12 days ago

Job description

Position Summary:
The Regulatory Device Specialist prepares and submits high quality routine regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. They will also support the preparation, review and archival of electronic and paper regulatory submissions ensuring compliance with FDA and other Health Authorities, company policies and procedures under the guidance of regulatory management.
This position serves as a subject matter expert on various domestic and foreign regulations for medical devices.
  • Reports to: Regulatory Affairs Manager
  • Location: Remote with occasional travel
  • Salary: *$65,000-$73,000 annually + annual performance bonus

*The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location.
Essential Roles and Responsibilities:
  • Prepare pre-market submission reports / technical files per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU, APAC, Middle East).
  • Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
  • Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission).
  • Assist in the update, enhancement, and creation of internal policies and procedures.
  • Supports regulatory compliance to QSR, ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.
  • Compile, submit, and manage international product registrations, license renewals, and registration amendments, including FDA 510(k)s, Health Canada Medical Device Licences, EU MDR Technical Documentation, UKCA, TGA (Australia), PMDA (Japan), ANVISA (Brazil), NMPA (China), MFDS (South Korea), COFEPRIS (Mexico), SFDA (Saudi Arabia), and MOHAP (UAE).
  • Prepare and manage export and country-specific documentation, including Certificates to Foreign Government (CFG), Certificates of Free Sale, Declarations of Conformity, ISO 13485/MDSAP certificates, and Letters of Authorization, and coordinate notarization, apostille, legalization, and consularization as required.
  • Assess new market opportunities by determining device classification, registration pathway, submission content, expected timelines, and in-country representation requirements; provide registration strategy input to new product launch and market entry plans.
  • Review labeling, Instructions for Use, and promotional materials for country-specific content, symbols, translation, and UDI requirements, and support product data submissions to GUDID, EUDAMED, and other national registries.
  • Support Notified Body, MDSAP, and international regulatory inspections and audits, including preparation of requested documentation and follow-up on findings and nonconformities.
  • Monitor and interpret evolving global regulations and guidance (e.g., EU MDR, UKCA transition, IMDRF harmonization initiatives), assess business impact, and communicate required actions to cross-functional stakeholders.
  • Perform other duties as assigned.

Preferred Experience:
  • Minimum of 3 years Medical Device Regulatory Experience required; aesthetics experience preferred
  • Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and EU MDR requirements
  • Demonstrated experience obtaining and maintaining medical device registrations in at least three major markets outside the United States (e.g., EU, UK, Canada, Australia, Japan, China, Brazil, LATAM, Middle East, or APAC).
  • Hands-on experience authoring or compiling regulatory dossiers in multiple formats, including FDA 510(k), EU MDR 2017/745 Technical Documentation, IMDRF/STED Table of Contents, and ASEAN CSDT submissions.
  • Working knowledge of MDSAP, UKCA, and Notified Body review processes, and of country-specific labeling, translation, and UDI/registry requirements.
  • Ability to manage multiple concurrent international submissions across time zones

Preferred Education:
  • Bachelor's degree from a four year college or university.

Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
What Revance invests in you:
  • Competitive Compensation including base salary and annual performance bonus.
  • Flexible PTO, holidays, and parental leave.
  • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

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