Director Biostatistics
OR · Remote
$200K - $230K/yr
Medical
Dental
Vision
Retirement
... FDA * Collaborate cross-functionally with Clinical, Medical, and Regulatory * Oversee CROs and/or ... US Salary Range: $200,000 - $230,000 #LI-Remote
OR · Remote
$200K - $230K/yr
Medical
Dental
Vision
Retirement
... FDA * Collaborate cross-functionally with Clinical, Medical, and Regulatory * Oversee CROs and/or ... US Salary Range: $200,000 - $230,000 #LI-Remote
OR · Remote
$200K - $230K/yr
Medical
Dental
Vision
Retirement
... FDA * Collaborate cross-functionally with Clinical, Medical, and Regulatory * Oversee CROs and/or ... US Salary Range: $200,000 - $230,000 #LI-Remote
OR · Remote
About the Role Gruve is seeking a Full Stack Developer to help modernize a legacy remote instrument ... Experience developing software for medical devices or regulated environments (IEC 62304, FDA CFR ...
New
OR · Remote
About the Role Gruve is seeking a Full Stack Developer to help modernize a legacy remote instrument ... Experience developing software for medical devices or regulated environments (IEC 62304, FDA CFR ...
New
OR · On-site +1
$115K - $178K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Remote and on-site * Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) * Demonstrated ability to evaluate medical ...
OR · On-site +1
$115K - $178K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Remote and on-site * Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) * Demonstrated ability to evaluate medical ...
OR · Remote
$340K - $370K/yr
Medical
Dental
Vision
Retirement
... remote company. Executive Director, Clinical Development The Executive Director, Clinical ... Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA ...
OR · Remote
$340K - $370K/yr
Medical
Dental
Vision
Retirement
... remote company. Executive Director, Clinical Development The Executive Director, Clinical ... Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA ...
OR · Remote
$190K - $225K/yr
Medical
Dental
Vision
Retirement
... a fully remote company. Our Medical Affairs team is growing and hiring Senior Medical Science ... EEO FDA, OSHA, PDMA, EPA PhRMA, etc.) * Contribute to medical affairs metrics, qualitative and ...
OR · Remote
$190K - $225K/yr
Medical
Dental
Vision
Retirement
... a fully remote company. Our Medical Affairs team is growing and hiring Senior Medical Science ... EEO FDA, OSHA, PDMA, EPA PhRMA, etc.) * Contribute to medical affairs metrics, qualitative and ...
OR · On-site +1
San Diego, United Kingdom - Remote, USA- Remote Be a part of a global team that is inspired to make ... Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to ...
OR · On-site +1
San Diego, United Kingdom - Remote, USA- Remote Be a part of a global team that is inspired to make ... Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to ...
Remote (United States) Department: Pharmacovigilance Reports To: Global Head of Pharmacovigilance ... Food and Drug Administration (FDA) * European Medicines Agency (EMA) * Japan Pharmaceuticals and ...
Remote (United States) Department: Pharmacovigilance Reports To: Global Head of Pharmacovigilance ... Food and Drug Administration (FDA) * European Medicines Agency (EMA) * Japan Pharmaceuticals and ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · On-site +1
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Medical
Dental
Vision
PTO
Each year, the FDA approves ~6,000 new medical devices. Our solution helps MedTech companies get ... Remote work : AcuityMD is committed to supporting full-remote flexibility for employees in the US.
OR · On-site +1
$175K - $215K/yr
Medical
Dental
Vision
PTO
Each year, the FDA approves ~6,000 new medical devices. Our solution helps MedTech companies get ... Remote work : AcuityMD is committed to supporting full-remote flexibility for employees in the US.
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
Medical
Dental
Vision
Life
Retirement
Minimum 2 years prior sales experience in an FDA or other regulated business preferred * Experience ... LI-Remote We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to ...
OR · Remote
$265K - $290K/yr
Medical
Dental
Vision
Retirement
... Mineralys is a fully remote company. The Sr. Director, Scientific Communications & Medical ... g., FDA, OIG, PhRMA, and international equivalents). * Proven ability to establish and manage a ...
New
OR · Remote
$265K - $290K/yr
Medical
Dental
Vision
Retirement
... Mineralys is a fully remote company. The Sr. Director, Scientific Communications & Medical ... g., FDA, OIG, PhRMA, and international equivalents). * Proven ability to establish and manage a ...
New
OR · Remote
$309K/yr
Medical
Dental
Vision
PTO
Remote (U.S.) We are seeking Ethics & Compliance Attorneys to join our Life Sciences team. In this ... Drafting responses to regulatory inquiries and supporting clients in preparation for FDA ...
OR · Remote
$309K/yr
Medical
Dental
Vision
PTO
Remote (U.S.) We are seeking Ethics & Compliance Attorneys to join our Life Sciences team. In this ... Drafting responses to regulatory inquiries and supporting clients in preparation for FDA ...
OR · On-site +1
Medical
Dental
Vision
Retirement
PTO
Remote or On-Site in Boulder, CO (Foresight Dx business unit, a Natera company) Foresight ... FDA, CAP/CLIA), including documentation and traceability of requirements and deliverables.
OR · On-site +1
Medical
Dental
Vision
Retirement
PTO
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Medical
Dental
Vision
Life
Retirement
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Strong knowledge of regulatory requirements (GCP, ICH, FDA/NIH guidelines). * Proven ability to ... REMOTE
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Dental
Vision
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Retirement
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Strong knowledge of regulatory requirements (GCP, ICH, FDA/NIH guidelines). * Proven ability to ... REMOTE
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OR · On-site +1
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Dental
Vision
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OR · On-site +1
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Dental
Vision
PTO
Remote (U.S.) We are seeking Market Access Attorneys to advise our Life Sciences clients. In this ... FDA regulations, the Federal Food, Drug, and Cosmetic Act (FDCA), federal and state Anti-Kickback ...
Knowledge in interpreting and adhering to FDA regulations regarding product promotion, scientific ... Remote
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OR · On-site +1
$309K/yr
Medical
Dental
Vision
PTO
Lead and participate in MLR (Medical, Legal & Regulatory) reviews to ensure promotional content complies with FDA, FTC and other applicable regulations. * Work closely with cross-functional teams ...
OR · On-site +1
$309K/yr
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Dental
Vision
PTO
Lead and participate in MLR (Medical, Legal & Regulatory) reviews to ensure promotional content complies with FDA, FTC and other applicable regulations. * Work closely with cross-functional teams ...
$25.9K - $39.4K
12% of jobs
$50.1K is the 25th percentile. Wages below this are outliers.
$39.4K - $52.9K
17% of jobs
$52.9K - $66.3K
14% of jobs
The median wage is $75.5K / yr.
$66.3K - $79.8K
12% of jobs
$79.8K - $93.3K
12% of jobs
$105.7K is the 75th percentile. Wages above this are outliers.
$93.3K - $106.7K
11% of jobs
$106.7K - $120.2K
7% of jobs
$120.2K - $133.7K
6% of jobs
$133.7K - $147.1K
4% of jobs
$147.1K - $160.6K
4% of jobs
$160.6K - $174K
2% of jobs
$25.9K
$88.4K
$174K
A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.
A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.
To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.
The most popular types of Fda jobs in Oregon are:
For Remote Fda jobs in Oregon, the most frequently searched job titles are:
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$200K - $230K/yr
Full-time
Medical, Dental, Vision, Retirement
Posted 14 days ago
"Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky"
Mineralys is a fully remote company.
Director Biostatistics
The Director, Biostatistics will lead the full scope of statistical strategy and execution for clinical development programs at Mineralys. This individual is accountable for the design, analysis, and interpretation of clinical trials, as well as statistical contributions to regulatory submissions, including NDA readiness.
Operating in a fast-paced, pre-commercial biotech environment, this role requires a strong balance of strategic thinking and operational oversight, with high visibility across Clinical, Medical, and Regulatory teams.
Key Responsibilities
Qualifications
Core Competencies
Travel
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $200,000 - $230,000
#LI-Remote
Sourced by ZipRecruiter
Biotechnology research and development
1 - 10 Employees
Radnor, PA, US
2020