Medical Writer
About The Position
Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer ! I This is an entry level medical writer role, that will require 5 years experience in a medical background. In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare. This is a REMOTE opportunity.
Requirements
- Associate’s degree in clinical research, health sciences, or a related field.
- 5+ years of experience in a medical setting, ideally as a CST, CSFA, or RN.
Nice To Haves
- Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance.
- Proficiency in creating PMS plans, PMSRs, or PSURs.
- Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP).
- Understanding of medical device regulations and adverse event reporting.
Responsibilities
- Develop and refine strategies and processes for market and customer feedback collection.
- Assist in creating medical device market research protocols and Case Report Forms.
- Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.
- Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.
- Keep relevant procedures up-to-date .
- Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746)
- Create market research protocols, deploy questionnaires, and compile technical reports.
- Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)
- Author and update post-market surveillance plans for upcoming and existing medical devices.
- Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.
- Ensure timely creation of deliverables to prevent project delays.
- Develop proactive customer feedback templates and process workflows.
- Communicate roadblocks and escalate issues promptly to stakeholders.
Benefits
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
1,001-5,000 employees
