R&D Partners is seeking to hire a Clinical Evaluations Specialist Regulatory Documentation in Johns Creek, GA .
Your main responsibilities as a Clinical Evaluations Specialist Regulatory Documentation:
Author, revise, and update clinical documents for MDR remediation and PPRRs.
Conduct systematic literature reviews and clinical data appraisals in alignment with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidance.
Review and summarize large clinical documents such as literature reports, clinical research protocols, and templates.
Assist in the development and maintenance of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Plans and Reports, and risk-benefit analyses.
Support regulatory submissions by ensuring all clinical documentation meets scientific and regulatory standards.
What we are looking for in a Clinical Evaluations Specialist Regulatory Documentation:
Master s or Ph.D. in Vision Science, Biomedical Engineering, Life Sciences, or related field.
Foreign-trained ophthalmologists are encouraged to apply.
Proficiency in European Medical Device Regulations (MDR), particularly in clinical evaluations and post-market surveillance.
Experience in writing and reviewing clinical evaluation reports (CERs), literature reviews, and clinical risk assessments.
Strong background in regulatory compliance, medical writing, and scientific research methodologies.
Why Choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:
Pay Scale:
$120,577 $150,724 ( Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
...Senior Data Scientist Remote | United States Role Overview We are seeking an experienced Senior Data Scientist to join Property Leads , a fast-growing start-up specializing in lead generation and data solutions for real estate investors. This role is critical...
...extraordinary ability to capture an audience to create excitement with target demographics during promotional events and throughout the... ...and results-driven ~ Ability to work some nights and weekends for events and promotions ~ Excellent time management skills...
...inventors, and patent examiners - A strong work ethic paired with the ability to juggle multiple job responsibilities SUMMARY Vanguard Intellectual Partners (Vanguard-IP) specializes in the placement of IP/Patent professionals nationwide. Our sole focus on...
...Our client is seeking a highly skilled and experienced Captain (Pilot in Command - PIC) to join their team in providing critical air... ...preferred). ? Strong proficiency in Microsoft Office and aviation-related software. Key Competencies: ?? Safety First Mindset...
...Responsibilities Responsible for all activities relating to rail transportation which affect our facilities Responsible for coordinating... ..., dental and vision insurance ~ Health savings account, medical and dependent care flex spending accounts ~ Long term...