Regulatory Post Market Surveillance Specialist – Technical Writer

Job Post Index 2346E6-Sy##
Location Santa Clara, CA
Description: Description
  • Provides feedback to customers via Failure Analysis Letters.
  • Creation and distribution of failure analysis letters based on completed failure analysis results
  • Managing failure analysis letters and backlog using software systems such as SAP and Trackwise
  • Work with translation vendors, as required, for letters outside of US
  • Provide clarification on failure analysis letter content when requested
  • Escalate feedback, comments, or concerns from customers or distributors based on failure analysis letters provided to end user
  • Escalate complaints to the Post Market Investigation (PMI) group
  • Interface with Failure Analysis, Customer Service, engineering, RMA, and clinical teams to gather information required for failure analysis letter content
  • Maintain library of similar responses in reference to failure modes, root cause, IFU reminders, and recommendations
  • Participate in process improvement activities to continuously improve process effectiveness
  • Execute on projects
Skills: Requirements
  • Education – English, Journalism, or a Communications Undergraduate Degree.
  • Preferred Undergraduate degree in engineering, life science, or equivalent.
  • Experience with technical writing for a technical product and/or company.
  • Intern experience is accepted
  • 2-5 years experience
  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (SAP, Excel, Word, PowerPoint, database)
  • Efficient independent worker with ability to focus
  • Attention to detail along with strong analytical skills
  • Demonstrate cross functional communication skills in email and in person
  • Excellent organizational and analytical skills
  • Ability to handle and manage workload independently
  • Prioritize numerous activities in a rapid paced environment
  • Contribute to team oriented tasks
  • Strong interpersonal and decision making skills.
  • Having the ability to devote time and energy to the vital activities that will make a significant impact or difference
  • General understanding of technical writing and ability to simplify complex topics.
  • General understanding of quality records requirements and how they apply to complaint files.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
  • Materials background and experience with analyzing plastics, metals and any type of imaging techniques.
  • Isn’t afraid to be hands on and is comfortable with electronics
  • Experience working with 3rd parties reporting back failure analysis is helpful.
  • Preferred experience within the medical device field, with experience or exposure in the following areas:
    • Collaborating with engineering, scientists, and other specialists
    • General technical and or clinical medical device knowledge
    • Knowledge and understanding with Medical Device Complaint files and quality record documentation

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