Senior Clinical Affairs Specialist

5 - 7 years experience  •  Business Services

Salary depends on experience
Posted on 02/21/18
Boulder, CO
5 - 7 years experience
Business Services
Salary depends on experience
Posted on 02/21/18

A Day in the Life

  • Provide subject matter expertise to ensure on-time completion of Clinical EvaluationReports (CER) to substantiate the safety and performance of assigned medical devices in order to support product launches or recertification’s in various regions. (may require working with otherinternal or contract medical writers)
  • May be required to author CERs
  • Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as: Risk Management Plan, Product Risk Assessment, Design Failure Modes and Effects Analysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, and Post Launch Risk Management Review
  • Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented
  • Participates in comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, staying informed about applicable clinical landscapes and trends
  • Participates in and/or performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
  • Provide clinical perspective and support to guide new product development and/or post-market product sustainability for engineering core teams.  May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input
  • May participate in audits
  • Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures

Must Have:   Minimum Requirements  

  • Bachelor’s degreerequired
  • Minimum 5 years prior experience as a clinician (e.g., Clinical Nurse Specialist, Respiratory Therapist) on the medical/surgical floor or in the Intensive Care/Critical Care Unit  OR a combination of clinical and corporate experience.
  • Must hold an active, unencumbered license (within profession)

  Nice to Have:   

  • In-depth scientific and technical knowledge of, plus clinical experience with, Medtronic products and competitor’s products plus the disease states they are used to treat
  • Clinical experience with relevant types of devices and technologies (e.g., pulse oximetry, capnography, invasive and non-invasive ventilation, endotracheal and tracheostomy tubes, central/remote monitoring technology.
  • Experience conducting in-depth literature reviews and summarizing results
  • Experience writing complex medical or technical documentation in a manner that is easily understood by individuals with varying levels of technical and medical expertise
  • Experience form a contract research organization, pharmaceutical or biotechnology firm preferred.
  • Experience in the conduct of clinical research/medical communication preferred
  • Specialized medical writing knowledge
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