Required Skills & Experience: Bachelor's degree in a scientific or engineering field of study; 7+ years of experience in medical devices with at least 5 years of direct experience in CER writing; Expertise in medical device applicable regulations including but not limited to, MEDDEV 2.7.1, MDR, PMA, 510K, IDE and China (NMPA); Experience in the application of therapeutic and device knowledge to develop CERs; Strong experience in conducting literature searches, reviews and appraisal of scientific data; Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing; Ability to identify critical information needs and identify stakeholders within clinical evaluation assessment and report development; Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
Job Description: A large medical device company is looking for a REMOTE Medical Writer. The position will mainly focus on development of Annual Progress Reports (APRs), Clinical Evaluation Reports (CERs) and associated documents including Clinical Evaluation Plans (CEPs), Literature Search Protocols and Reports (LSPs/LSRs) and Post Market Clinical Follow-up (PMCF) Plans and Reports. The main purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. This job may be expanded to support other clinical evidence documents, including the support of the clinical sections of a Post-Approval Clinical Study Reports (PASRs), Annual Progress Reports (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as applicable.
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