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Remote Fda Jobs in Oregon (NOW HIRING)

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

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

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 ...

Senior Product Manager

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.

Program Manager

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.

Showing results 41-60

Remote Fda information

See Oregon salary details

$25.9K

$88.4K

$174K

How much do remote fda jobs pay per year?

As of Aug 14, 2026, the average yearly pay for remote fda in Oregon is $88,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $51,366.00 and $114,702.00 per year, depending on experience, location, and employer.

What are the typical daily responsibilities of a remote FDA compliance specialist?

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.

What is a remote FDA?

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.

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

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.

What are the most commonly searched types of Fda jobs in Oregon?

The most popular types of Fda jobs in Oregon are:

What cities in Oregon are hiring for Remote Fda jobs?

Cities in Oregon with the most Remote Fda job openings:

Infographic showing various Remote Fda job openings in Oregon as of August 2026, with employment types broken down into 80% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $88,412 per year, or $42.5 per hour.

$200K - $230K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 14 days ago


Job description

"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

  • Lead the full scope of Biostatistics activities for assigned clinical programs or indications
  • Define and execute statistical strategies for clinical trials and regulatory submissions
  • Design clinical studies, including endpoints, estimands, and sample size calculations
  • Serve as statistical lead on Study Executive Teams and Clinical Development Teams
  • Provide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success
  • Ensure quality and timely delivery of statistical outputs, including interim, final, and integrated analyses
  • Contribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDA
  • Collaborate cross-functionally with Clinical, Medical, and Regulatory
  • Oversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverables
  • Collaborate with internal leaders of Statistical Programming and Data Management
  • Supervise statistical programmers for QC and validation activities
  • Interpret analysis results and ensure accuracy in study reports, publications, and regulatory documents
  • Contribute to abstracts, posters, and presentations for internal and external stakeholders
  • Drive continuous improvement initiatives within Biostatistics and cross-functional processes

Qualifications

  • PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience
    OR MS with ~11+ years of experience in drug development
  • Pharmaceutical/biotech industry experience required
  • Demonstrated experience providing statistical leadership at study or program level
  • Strong experience designing clinical trials and collaborating with cross-functional teams
  • Experience supporting regulatory submissions (NDA/BLA)
  • Experience interacting with regulatory authorities preferred
  • Experience overseeing CROs or external vendors
  • Experience supervising programming deliverables or QC activities
  • Strong knowledge of CDISC standards, data structures, and statistical methodologies
  • Working knowledge of SAS and/or R (oversight level, not heavy programming)
  • Experience with outcomes research preferred
  • Therapeutic area experience flexible; preference for chronic diseases or larger patient populations

Core Competencies

  • Strong understanding of clinical development processes and regulatory expectations
  • Ability to lead and influence in a matrixed environment
  • Excellent communication skills; able to translate statistical concepts to non-statistical audiences
  • Demonstrated ability to balance urgency with quality
  • Analytical rigor with a pragmatic, execution-oriented mindset
  • Experience applying innovative statistical methodologies

Travel

  • This position requires up to 10% travel. Frequently travel is outside the local area and overnight.

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