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Medical Device Analyst Remote Jobs in Arizona (NOW HIRING)

Compile, analyze, and synthesize clinical evidence from clinical studies, published literature ... Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ...

The Position We are seeking a driven team player to join our SEO team as a Senior SEO Analyst. This ... Compensation Competitive benefits package - up to $75,000 DOE, including medical/dental/vision ...

Partnering with the world's leading medical device innovators, we design, develop, and manufacture ... This is a remote position with approximately 50%travelrequired. Yourhunter focusedrole will involve ...

... analysis,andstrategic thinking Preferred Qualifications * Demonstrated experience in project ... Experience working in a highly regulated industry, preferably within the Medical Device industry ...

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Medical Device Analyst Remote information

What does a medical device analyst do when working remotely?

A Medical Device Analyst working remotely is responsible for evaluating, monitoring, and reporting on the performance and compliance of medical devices. They analyze data from clinical trials, adverse event reports, and post-market surveillance to ensure devices meet regulatory standards and safety requirements. Remote analysts often collaborate with cross-functional teams via digital platforms, prepare detailed reports, and may assist with quality assurance or regulatory submissions without needing to be on-site.

What are the typical collaboration and communication expectations for a remote medical device analyst?

As a remote Medical Device Analyst, you'll frequently collaborate with cross-functional teams, including regulatory affairs, quality assurance, and engineering, often through virtual meetings and project management tools. Clear and proactive communication is essential to keep projects on track and ensure compliance with medical device regulations. You can expect regular check-ins, documentation sharing, and status updates to maintain alignment across distributed teams. Building strong virtual relationships and being comfortable with digital collaboration platforms are key to success in this role.

What are the key skills and qualifications needed to thrive as a remote medical device analyst, and why are they important?

To thrive as a Medical Device Analyst (Remote), you need a background in biomedical engineering, life sciences, or a related discipline, along with strong analytical and research abilities. Familiarity with regulatory databases, medical device reporting systems, and data analysis tools like Excel or SAS is typically required. Attention to detail, effective communication, and self-motivation are crucial soft skills for remote collaboration and accurate analysis. These competencies ensure precise evaluation of device safety and compliance while enabling efficient teamwork in a virtual environment.

What is the difference between Medical Device Analyst Remote vs Medical Device Quality Assurance Specialist?

AspectMedical Device Analyst RemoteMedical Device Quality Assurance Specialist
Required CredentialsBachelor's in life sciences or engineering, certifications like RAC or ISO auditorBachelor's in quality assurance, certifications like CQE or ISO auditor
Work EnvironmentRemote, primarily data analysis and reportingOn-site or hybrid, focusing on audits and process validation
Employer & Industry UsageMedical device companies, regulatory agencies, consulting firmsManufacturers, regulatory bodies, healthcare companies
Search & Comparison IntentUnderstanding remote roles in medical device analysisComparing quality assurance roles in medical devices

The Medical Device Analyst Remote role focuses on analyzing data, regulatory compliance, and reporting remotely, while the Medical Device Quality Assurance Specialist emphasizes on-site quality audits, process validation, and compliance checks. Both roles require similar certifications and industry knowledge but differ mainly in work environment and specific responsibilities.

What cities in Arizona are hiring for Medical Device Analyst Remote jobs?

Cities in Arizona with the most Medical Device Analyst Remote job openings:

Senior Staff Medical Writer (Remote)

Phoenix, AZ • On-site, Remote


Stryker
Medical Equipment and Supplies Manufacturing • 10K+ employees

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

131st of 495 rated machine equipment manufacturers

Great coworkers

People enjoy working here

Good employer


$143K - $238K/yr

Full-time

Posted 13 days ago


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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