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Remote Fda Jobs in Scappoose, OR (NOW HIRING)

Stryker

Senior Staff Medical Writer (Remote)

Portland, OR · On-site +1

$143K - $238K/yr

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international ...

micro1 AI

Compliance Officers

Hillsboro, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Director of Biostatistics

Hillsboro, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Biostatistician

Vancouver, WA · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Regulatory Affairs Specialist

Hillsboro, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Biostatistician

Portland, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Director of Biostatistics

Vancouver, WA · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Compliance Officers

Beaverton, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Regulatory Affairs Specialist

Beaverton, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Director of Biostatistics

Portland, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Compliance Officers

Vancouver, WA · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Biostatistician

Beaverton, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Regulatory Affairs Specialist

Portland, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Biostatistician

Hillsboro, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Director of Biostatistics

Beaverton, OR · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Regulatory Affairs Specialist

Vancouver, WA · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Compliance Officers

Portland, OR · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

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All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Scappoose, OR

Remote Fda information

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 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 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 jobs can I do completely remotely as a remote FDA?

A remote FDA typically refers to a Food and Drug Administration-related role that can be performed remotely, such as regulatory affairs specialists, quality assurance managers, or compliance analysts. These positions often require knowledge of regulations, strong communication skills, and familiarity with digital tools for document review and reporting, allowing work to be done entirely online. However, some roles may require occasional on-site visits or inspections depending on the specific job and employer policies.
Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Scappoose, OR as of August 2026, with employment types broken down into 50% Full Time, and 50% Part Time. Highlights an 100% Remote job distribution.

Senior Staff Medical Writer (Remote)

Stryker

Portland, OR • On-site, Remote

$143K - $238K/yr

Full-time

Posted 19 days ago

Key responsibilities

  • Author and maintain clinical and regulatory documentation such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents.

  • Compile, analyze, and synthesize clinical evidence from various sources into submission-ready regulatory documents.

  • Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.

Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

134th of 499 rated machine equipment manufacturers

Job description

Work Flexibility: Remote

Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based remotely anywhere within the United States. Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions.

As the Senior Staff Medical Writer, you will develop scientific and clinical documentation that supports global regulatory compliance and market access for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research & Development, and Marketing teams to translate complex clinical evidence into high-quality regulatory and scientific documents throughout the product lifecycle.

What You Will Do

  • Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.

  • Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-ready regulatory documents.

  • Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access.

  • Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.

  • Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.

  • Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation.

  • Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals.

  • Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members.

What You Need

Required

  • Bachelor's degree in a scientific, technical, healthcare, or related discipline.

  • Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products.

  • Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities.

  • Experience authoring Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documentation.

  • Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745), and Medical Device Coordination Group (MDCG) guidance for clinical evaluations.

  • Experience conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.

  • Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards.

Preferred

  • Master's degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree.

  • Experience authoring clinical study protocols, clinical study reports, manuscripts, or scientific publications.

  • Experience supporting regulatory submissions and global market access initiatives for medical devices.

  • Knowledge of clinical operations, risk management, and international regulatory requirements.

United States of America Pay Ranges:

  • USN: $110,100 - $183,400 USD Annual
  • US5: $115,600 - $192,600 USD Annual
  • US10: $121,100 - $201,700 USD Annual
  • US15: $126,600 - $210,900 USD Annual
  • US20: $132,100 - $220,100 USD Annual
  • US30: $143,100 - $238,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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