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Remote Fda Auditor Jobs (NOW HIRING)

Whoop

Director, Clinical Science

Boston, MA · On-site +1

$86K - $118K/yr

... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ... Experience interacting with FDA, Notified Bodies, auditors, or other regulatory agencies preferred.

Whoop

Director, Clinical Science

Boston, MA · On-site +1

$86K - $118K/yr

... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ... Experience interacting with FDA, Notified Bodies, auditors, or other regulatory agencies preferred.

Dyne Therapeutics

Director, Compliance

Waltham, MA · Remote

These topics include HCP and patient engagement, diseasestate education, compliance with FDA ... This role is based in Waltham, MA, without the possibility of being a remote role. Primary ...

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Remote Fda Auditor information

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How much do remote fda auditor jobs pay per year?

As of Jul 15, 2026, the average yearly pay for remote fda auditor in the United States is $76,256.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,500.00 and $98,500.00 per year, depending on experience, location, and employer.

What are some common challenges faced by Remote FDA Auditors, and how can they be managed effectively?

Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.

What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?

AspectRemote Fda AuditorRemote Quality Assurance Specialist
CertificationsFDA auditor certification, GxP, GMP, GLPISO, Six Sigma, GMP, GCP
Work EnvironmentRegulatory agencies, pharmaceutical, biotech companiesManufacturing, clinical trials, healthcare companies
Industry UsagePrimarily in pharma, biotech, medical devicesBroader across healthcare, manufacturing, biotech

The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.

What are Remote FDA Auditors?

Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.

What are the key skills and qualifications needed to thrive as a Remote FDA Auditor, and why are they important?

To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.
More about Remote Fda Auditor jobs
What cities are hiring for Remote Fda Auditor jobs? Cities with the most Remote Fda Auditor job openings:
What are the most commonly searched types of Fda Auditor jobs? The most popular types of Fda Auditor jobs are:
What states have the most Remote Fda Auditor jobs? States with the most job openings for Remote Fda Auditor jobs include:
What job categories do people searching Remote Fda Auditor jobs look for? The top searched job categories for Remote Fda Auditor jobs are:
Remote Fda Auditor jobs near you
Infographic showing various Remote Fda Auditor job openings in the United States as of July 2026, with employment types broken down into 64% Full Time, 27% Part Time, and 9% Contract. Highlights an 9% In-person, and 91% Remote job distribution, with an average salary of $76,256 per year, or $36.7 per hour.
Director, Clinical Science

Director, Clinical Science

Whoop

Boston, MA • On-site, Remote

$86K - $118K/yr

Full-time

Re-posted 6 days ago

Job description

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. WHOOP empowers members to improve their health through a deeper understanding of their bodies and daily lives.

As the Director, Clinical Science, you will lead the clinical science function responsible for developing the evidence that supports WHOOP’s regulated and unregulated health features, with a particular focus on Software as a Medical Device (SaMD). You will own clinical strategy across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence generation.

This role requires deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy, and evidence generation. As both a strategic leader and hands-on expert, you will partner closely with cross-functional teams to ensure clinical evidence supports product, regulatory, and business objectives.

You will build and mentor a high-performing team of Clinical Scientists, strengthen WHOOP’s clinical science capabilities, and ensure our evidence generation strategy meets the expectations of regulators, clinicians, members, and the business.

RESPONSIBILITIES:
  • Own the clinical evidence strategy across WHOOP’s portfolio of regulated and unregulated health features, including feasibility, validation, regulatory submission, launch, and post-market evidence generation.
  • Translate product concepts and algorithms into clinically meaningful indications, claims, endpoints, and evidence strategies.
  • Define clinical validation strategies, including study design, comparator selection, endpoint development, sample size justification, statistical analysis planning, success criteria, and evidence requirements.
  • Lead the design and oversight of feasibility, validation, and post-market studies supporting product development and regulatory objectives.
  • Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways, including participation in regulatory interactions and review of clinical content for submissions.
  • Develop, review, and approve key clinical deliverables, including protocols, CRFs, SAPs, CSRs, CERs, and regulatory submission content.
  • Serve as the clinical and scientific subject matter expert for internal stakeholders, regulators, investigators, advisors, and external partners.
  • Partner closely with Product, Data Science, Engineering, Regulatory, Quality, Legal, and Commercial teams to ensure clinical evidence informs product, regulatory, and business decisions.
  • Build and lead a high-performing Clinical Science organization, including hiring, mentoring, workforce planning, and establishing scalable processes, standards, and operating models.
  • Communicate complex scientific, clinical, and regulatory concepts to technical and non-technical stakeholders, including executive leadership.
QUALIFICATIONS:
  • Advanced degree (PhD, MD, PharmD, DrPH, MPH/MS with significant relevant experience, or equivalent) in life sciences, medicine, public health, epidemiology, biostatistics, or a related field.
  • 10+ years of experience in clinical science, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
  • 5+ years of experience leading and developing clinical science or clinical research teams.
  • Demonstrated experience leading clinical evidence generation for regulated products, ideally including Software as a Medical Device (SaMD) or digital health technologies.
  • Deep expertise in clinical study design, endpoint development, clinical validation, statistical analysis planning, and evidence generation strategy.
  • Experience supporting FDA, CE Mark, or other regulatory submissions, including development of clinical evidence and participation in regulatory interactions.
  • Experience authoring and reviewing key clinical and regulatory deliverables, including protocols, SAPs, CSRs, CERs, and submission documentation.
  • Strong understanding of medical device and SaMD regulatory requirements, standards, and guidance.
  • Proven ability to influence cross-functional stakeholders and drive decisions across Product, Data Science, Engineering, Regulatory, Quality, and Executive Leadership.
  • Excellent written and verbal communication skills, with the ability to translate complex scientific and regulatory concepts for diverse audiences.
  • Preferred experience with wearable technologies, digital biomarkers, cardiovascular health, women’s health, sleep, metabolic health, or remote patient monitoring.
  • Familiarity with machine learning-enabled medical devices, algorithm validation, and software development lifecycles preferred. 
  • Experience interacting with FDA, Notified Bodies, auditors, or other regulatory agencies preferred. 
  • Experience working in both sponsor and CRO environments preferred.
  • Working knowledge of statistical and data analysis tools such as R, SAS, Python, SQL, CDISC, SDTM, or ADaM preferred.
  • Experience building or scaling a clinical science function within a growing organization preferred. 
This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. 
 
Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
 
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility.  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
 
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
 
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success.
 
The U.S. base salary range for this full-time position is $220,000-$245,000 Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. 
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
 
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.
 
Learn more about WHOOP.
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About Whoop

Sourced by ZipRecruiter

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers users (Olympians, Professional Athletes, Fitness Enthusiasts, etc) to perform at a higher level through a deeper understanding of their bodies and daily lives.

Industry

Fitness and sports centers

Company size

501 - 1,000 Employees

Headquarters location

Boston, MA, US

Year founded

2012

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