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Full Time Cer Writer Jobs (NOW HIRING)

Lee Health

Lead Instrument Technician

Fort Myers, FL · On-site

$25.06 - $32.58/hr

Sterile Processing Work Type: Full Time Shift: Shift 2/10:00:00 PM to 6:30:00 AM Minimum to ... HSPA CIS,CER Certification preferred. Other: Read,write, and speak English for work related ...

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Full Time Cer Writer information

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How much do full time cer writer jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for full time cer writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

What is a Full Time CER Writer?

A Full Time CER Writer is a professional who specializes in creating Clinical Evaluation Reports (CERs) for medical devices. These reports are essential for regulatory submissions, demonstrating the safety and performance of medical devices in accordance with regulations such as the EU Medical Device Regulation (MDR). CER Writers gather, analyze, and synthesize clinical data, literature, and post-market surveillance information to support device approvals and continued compliance. Working full time, they often collaborate with regulatory, clinical, and quality teams to ensure comprehensive and accurate documentation. Their role is crucial for medical device manufacturers seeking to bring products to market or maintain regulatory approval.

What are the key skills and qualifications needed to thrive as a Full Time CER Writer, and why are they important?

To thrive as a Full Time CER (Clinical Evaluation Report) Writer, you need a solid background in medical writing, regulatory requirements, and clinical research, often supported by a degree in life sciences or related fields. Familiarity with regulatory databases, literature review tools, and standards such as MEDDEV 2.7/1 or MDR is typically required. Excellent analytical thinking, attention to detail, and strong written communication are crucial soft skills for interpreting data and crafting clear, compliant reports. These competencies ensure the production of accurate, regulatory-compliant CERs that support product safety and market approval.

What is the difference between Full Time Cer Writer vs Part Time Cer Writer?

AspectFull Time Cer WriterPart Time Cer Writer
Work HoursTypically 35-40 hours per weekLess than 20 hours per week
CredentialsUsually requires certification and experience in medical writingMay require similar credentials but often less experience needed
Work EnvironmentFull-time employment, often with benefitsFlexible, often freelance or contract-based
Industry UsageCommon in healthcare organizations and medical writing firmsUsed by freelancers and part-time medical writers

Full Time Cer Writers work regular hours with benefits and are employed by organizations, while Part Time Cer Writers typically work fewer hours, often as freelancers or contractors. Both roles require similar credentials but differ mainly in hours and employment status.

What are some common challenges faced by Full Time CER Writers when preparing clinical evaluation reports, and how can they be addressed?

Full Time CER Writers often encounter challenges such as gathering comprehensive clinical data, staying compliant with evolving regulatory standards, and collaborating with cross-functional teams like clinical, regulatory, and medical affairs. Managing tight deadlines and ensuring the accuracy of scientific content can also be demanding. To address these, it's important to establish clear communication channels, maintain up-to-date knowledge of regulatory guidelines (such as MDR and MEDDEV), and use robust project management tools to track progress and document revisions.
More about Full Time Cer Writer jobs
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What job categories do people searching Full Time Cer Writer jobs look for? The top searched job categories for Full Time Cer Writer jobs are:
Full Time Cer Writer jobs near you

Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services

Criterion Edge Professional Services Inc.

Los Angeles, CA • Remote

Full-time

Posted 4 days ago

Job description

Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services 

Job Type: Full-Time, Remote 

Experience Level: Experienced 

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory-compliant performance evaluation reports (PER) projects with top industry clients. 

In the role of Associate Medical Writer, you will have the opportunity to work closely with other writers, project managers and project support specialists to support and lead multiple PER writing projects that support EU IVDR submission requirements for the client’s portfolio of IVD products. Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role. 

The ideal candidate is looking to build their medical writing career and should possess basic scientific knowledge and well-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that align with the highest professional standards. 

Specific responsibilities include: 

As a support member on our project writing team, you will actively collaborate and work together with other members of the project writing team to produce assigned written documents and reports to a high standard.  Your specific responsibilities include: 

  • Take direction from other members of the project writing team on assigned writing tasks.  

  • Plan and organize your workload on assigned projects and tasks and adhere to established project timelines and workload estimates.  

  • Understand client and project expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.  

  • Consistently monitor your work for accuracy and quality by following established internal QC processes. 

  • Work with Criterion Edge Project Manager to accurately document your assigned project tasks, task timeline estimates and assignments into the project plan. Provide weekly progress updates. 

  • Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges.  Seek understanding and additional clarity from the Project Lead and/or Project Management before proceeding.  

  • Establish and maintain effective working relationships with co-workers, managers, and clients. 

  • Attend internal meetings as needed.   

  • Required Experience: 

  • Previous experience writing CERs and/or PERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR 

  • Effective written, verbal and presentation skills in technical/laboratory diagnostics 

  • Strong command of medical and laboratory terminology 

  • Demonstrated ability to identify and adapt to shifting priorities and competing demands 

  • Skilled in document development and management using Word, Excel, PowerPoint and EndNote 

  • Training and degree in science, engineering, or medical field(s). Scientific/research background required, with a deep understanding of research design, methodology, and statistics 

If interested, please submit a resume/CV and a cover letter to careers@criterionedge.com. For more job openings, check out our careers page.  

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