Spec 2

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Job description

The Technical/Medical Writer is responsible for writing clinical evaluations for CE technical documentation in accordance with the requirements of ISO 14155 and MEDDEV.2.7.1, and EU MDR. This primarily involves literature searches, analyzing available safety and performance data for a medical device (e.g., from clinical trials, published literature, etc.) and preparing technical reports (Clinical Evaluation Reports) to demonstrate the device's technical and clinical performance. This role will support Technical Documentation (TD) remediation efforts to support EU MDR certification submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

Participate as the Clinical Representative in Cross-functional teams. Prepare Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for technical documentation in compliance with applicable regulations (e.g., MEDDEV 2.7.1, ISO 14155, EU MDR, etc.) and company procedures.

Perform clinical evidence gap assessments for assigned project teams, Update existing CERs to meet EU MDR regulation standards.

Collaborate with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives. Responsible for ensuring that assigned plans and reports are self-checked for errors, grammar, accuracy before approval, and that documents are routed correctly in the document control process. Responsible for following up on approvals of documents and ensuring that the CERs are released in the electronic document system timely.

Obtain required approvals and ensure that Clinical Evaluation readiness according to the required EU MDR Submission schedule. Participate in work streams and or process improvement initiatives.

Other duties as assigned (i.e Post-Market EU MDR project assignments)

QUALIFICATIONS/EXPERIENCE/EDUCATION:

Bachelor's degree in a relevant field or clinical/medical subject area (e.g., Biology, RN, PA, etc.) with 5 years of professional experience.

Master's Degree, or clinical/medical subject area with 5 years of professional experience is strongly preferred.

Scientific research, medical writing, or medical device industry or a combination of education and experience preferred.

This position requires demonstrated experience in high quality medical/technical writing and excellent written and oral communication skills.

Prior experience performing clinical evaluations according to MEDDEV 2.7.1 and EU MDR, and systematic literature reviews is strongly preferred.