You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific ...
Quick apply
You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific ...
Quick apply
You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific ...
You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific ...
Quick apply
You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific ...
Sunnyvale, CA · On-site
Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred. Additional Information Due to the nature of our business and the role, please note ...
Sunnyvale, CA · On-site
Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred. Additional Information Due to the nature of our business and the role, please note ...
Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred. Additional Information Due to the nature of our business and the role, please note ...
Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred. Additional Information Due to the nature of our business and the role, please note ...
... reports * You're able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and ...
... reports * You're able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and ...
... reports * You're able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and ...
... reports * You're able to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and ...
Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project ... Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to ...
Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project ... Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to ...
Knowledge of regulatory requirements relative to medical devices including Clinical Evaluation Reports and Post Market Requirements * Ability to write and edit quality medical abstracts, white papers ...
Knowledge of regulatory requirements relative to medical devices including Clinical Evaluation Reports and Post Market Requirements * Ability to write and edit quality medical abstracts, white papers ...
... for a clinician who is passionate about helping children and families through the evaluation ... Strong diagnostic, assessment, and report-writing skills * Commitment to evidence-based and family ...
Quick apply
... for a clinician who is passionate about helping children and families through the evaluation ... Strong diagnostic, assessment, and report-writing skills * Commitment to evidence-based and family ...
... written evaluation deliverables in support of MilTech requirements ... This position is responsible for producing structured reports that document the evaluation of ...
... written evaluation deliverables in support of MilTech requirements ... This position is responsible for producing structured reports that document the evaluation of ...
The Medical Writer Specialist is responsible for preparation of documents that support the ... Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to ...
The Medical Writer Specialist is responsible for preparation of documents that support the ... Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to ...
$120K - $190K/yr
Ability to write research reports for independent review. * Experience with test protocols and clinical evaluations * Highly motivated * Strong analytical skills * Passionate about learning
$120K - $190K/yr
Ability to write research reports for independent review. * Experience with test protocols and clinical evaluations * Highly motivated * Strong analytical skills * Passionate about learning
Kennesaw, GA · On-site
Knowledge of regulatory requirements relative to medical devices including Clinical Evaluation Reports and Post Market Requirements * Ability to write and edit quality medical abstracts, white papers ...
Kennesaw, GA · On-site
Knowledge of regulatory requirements relative to medical devices including Clinical Evaluation Reports and Post Market Requirements * Ability to write and edit quality medical abstracts, white papers ...
OR · Remote
$120K - $190K/yr
Ability to write research reports for independent review. * Experience with test protocols and clinical evaluations * Highly motivated * Strong analytical skills * Passionate about learning
Quick apply
OR · Remote
$120K - $190K/yr
Ability to write research reports for independent review. * Experience with test protocols and clinical evaluations * Highly motivated * Strong analytical skills * Passionate about learning
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
Quick apply
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and ...
Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and ...
Los Angeles, CA · On-site
$114 - $228/hr
Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and ...
New
Los Angeles, CA · On-site
$114 - $228/hr
Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and ...
New
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
Quick apply
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
Quick apply
$115K - $120K/yr
... Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: * Perform on-line external vigilance reviews and compare results to the Risk Management File.
$115K - $120K/yr
... Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: Perform on-line external vigilance reviews and compare results to the Risk Management File.
$115K - $120K/yr
... Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs). About the Role: Perform on-line external vigilance reviews and compare results to the Risk Management File.
$42K - $50.5K
16% of jobs
$54.5K is the 25th percentile. Wages below this are outliers.
$50.5K - $59.1K
20% of jobs
$59.1K - $67.6K
8% of jobs
The median wage is $71.9K / yr.
$67.6K - $76.2K
12% of jobs
$76.2K - $84.7K
15% of jobs
$84.7K - $93.3K
3% of jobs
$95.1K is the 75th percentile. Wages above this are outliers.
$93.3K - $101.8K
6% of jobs
$101.8K - $110.4K
17% of jobs
$110.4K - $118.9K
0% of jobs
$118.9K - $127.5K
0% of jobs
$127.5K - $136K
3% of jobs
$42K
$78.9K
$136K
To thrive as a Clinical Evaluation Report Writer, you need a solid understanding of clinical research, regulatory requirements (such as MDR or IVDR), and scientific writing, typically supported by a degree in life sciences or a related field. Familiarity with literature review databases, referencing software (e.g., EndNote), and document management systems is crucial. Strong attention to detail, analytical thinking, and effective communication skills help you excel in collaborating with cross-functional teams and interpreting complex data. These competencies ensure that your reports are accurate, compliant, and contribute positively to the approval and ongoing monitoring of medical devices.
A Clinical Evaluation Report (CER) Writer is responsible for preparing clinical evaluation reports required for medical device regulatory submissions. They analyze clinical data, review scientific literature, and ensure compliance with regulations like EU MDR and FDA guidelines. Their role involves collaborating with regulatory, clinical, and engineering teams to present accurate clinical evidence supporting a device’s safety and performance. Strong writing skills, regulatory knowledge, and an understanding of medical and scientific principles are essential for this role.
A typical day for a Clinical Evaluation Report Writer involves reviewing scientific literature, analyzing clinical data, and drafting or updating Clinical Evaluation Reports (CERs) in compliance with regulatory standards. You will often work closely with regulatory affairs, clinical, and quality assurance teams to ensure the report meets submission requirements and addresses feedback from notified bodies. The role also includes conducting gap analyses, maintaining documentation, and staying up to date with relevant clinical guidelines. While the work is largely independent, frequent collaboration and clear communication with other departments are essential for success.

Contractor
Re-posted 29 days ago
Job Title - Clinical Development Scientist;
Hybrid role. 3 days/week in office
Bothell WA/Cambridge MA/ Plymouth MN
12 Months
Ultrasound, Senior Clinical Development Scientist The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence. Your role: Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business. Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management. Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data. Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access. Ensure appropriate preparation, interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned. Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.
You are the right fit if:
You have acquired 7+ years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation. You have deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics. Your skills include a demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices. You have strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired. You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications. You have a medical or scientific education (MD or PhD). You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. You are self-directed with a strong work ethic, agile, and have an ability to work in a purposeful environment. You can collaborate effectively and influence decision making with various teams cross-functionally, as well as externally. You can think analytically, present statistical methods and results to a variety of audiences, especially non-statisticians. You can travel up to 15% (domestic and international) according to business needs.,
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It services
201 - 500 Employees
Irving, TX, US
1996