Medical Document Specialist
5 days ago
Overview
We are seeking a skilled Medical Document Specialist to join our team at CONMED Corporation. As a key member of our Clinical Solutions group, you will play a critical role in researching, creating, editing, and coordinating the production of clinical documents.
About the Role
The successful candidate will be responsible for planning and developing high-quality clinical documents to support Medical Solutions devices. This includes preparing and authoring Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Summary of Safety and Clinical Performance Reports (SSCPs) as required by EU regulations for CE marked devices.
You will work closely with internal teams to gain cross-functional inputs and approvals, consistently applying global regulations and guidelines, as well as ConMed policies and procedures. Your expertise will also be utilized in synthesizing responses to inquiries from the Notified Body, performing comprehensive literature searches, and participating in audits.
Responsibilities
- Develop and manage CER project plans and timelines
- Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner
- Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process
- Maintain and update spreadsheets tracking the status for CER projects
- Collect and maintain all documents necessary to ensure compliance with SOP
Requirements
- Associates degree required
- 1 year medical device and CER writing experience required
- Preferred Bachelors in a relevant discipline
- 2+ medical device and CER writing experience preferred
Benefits
- Competitive salary: $80,000 - $110,000 per annum
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance
- Retirement Savings Plan (401K)
- Employee Stock Purchase Plan
- Tuition assistance for undergraduate and graduate level courses
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