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Paragon 28, a Zimmer Biomet Company focused on medical devices and instrumentation for the foot and ankle, is hiring a Clinical Affairs Associate to join our team based in Englewood, Colorado. The Clinical Affairs Associate II provides support of pre-market product development and post-launch clinical activities. This includes development of product surgical technique guides, both for regulatory and marketing purposes, performing literature searches, drafting protocols, reviewing design and risk documentation, and executing simple pre-clinical testing and supporting anthropometric studies. This role coordinates product-testing lab activities, ensuring equipment and parts are available as well as managing scheduling for concurrent and subsequent labs.. This role also assists in collecting post-market surveillance data in the form of post-market clinical follow-up surveys.

Independently guide development and gain approval for product surgical technique guides, both for regulatory and marketing purposes. May work with outside departments as well as surgeon consultants to ensure the accuracy and relevancy of the surgical technique guide.
o Writing, editing, proofreading and layout oversight in educational materials and labeling to ensure medical accuracy and appropriate product representation.
o Collaborate with engineering to gather appropriate files, images or videos for accurate product representation and coordinate with Regulatory to ensure labeling requirements are met
o Work with graphics and medical illustration team to ensure accuracy in the surgical technique guide and other instructional material.
Actively assist in cadaver labs for assigned products, whether on-site or at surgeon facility.
o Create schedule for in-house product testing labs, in order to meet engineering timelines. Prepare lab space and equipment prior to lab and clean up station after lab.
Collaborate with marketing and sales management to review and provide feedback for desired claims for assigned products.
Perform medical journal searches and generate reports or summaries based on findings.
o Use literature searches to provide inputs for risk/benefit analysis, as well as providing historical procedural complications and incremental improvements.
Actively seek post-market surveillance data from internal (sales agents) and external (physician) stakeholders.
Assist in generating and proofreading educational materials, as requested.
Writing, editing, proofreading and layout oversight in educational materials and labeling to ensure medical accuracy and appropriate product representation. Present findings to internal stakeholders with suggested changes. Provide clinical approval, as appropriate.
Identify and report problems, investigate alternatives, and make recommendations for process improvement, as needed.
Other duties as assigned

Bachelor's degree required, preferably in Biology, Anatomy or Biomedical Science or related
3+ years medical device experience preferred but not required in lieu of previous healthcare, academic, or medical experience
Strong understanding of FDA and ISO Regulatory Requirements is preferred
Strong command of medical terminologyis preferred
Experience with searching medical literature and journal article retrieval required
Experience with basic data analysis and technical writing required; basic understanding of statistics helpful
Experience with clinical, biomechanical or life sciences research helpful
Must have effective proofreading and editing skills
Strong analytical, problem solving and leadership skills
Excellent written and oral communicator
Fluent in MS Office Suite (Word, Excel, Outlook)
Attention to detail
Proactive problem-solver who can work independently

Less than 10% of overnight travel.

Salary Range: $68,000 - $82,000 depending on skills and experience