Post Market Safety and Compliance Writer (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title:                     Post Market Safety and Compliance Writer

Department:                 QA - Post Market Quality Assurance

FLSA Status:                      Exempt

Position Overview:

• Review, analyze, and compose responses to regulatory agencies regarding medical device reportable events and collaborate both within post market surveillance and across other functions, including quality, clinical and regulatory to help ensure compliance with reporting requirements and good documentation practices.
• This position reports to the Senior Manager EMEA Product Monitoring QA/RA

Responsibilities:

• The incumbent will:

• Support activities for global vigilance reporting; Collaborate with other functions to compile compliance documentation for post market;.
• Critically interpret results of trending reports, failure investigations/engineering reports and determines how to present the data most effectively in a succinct manner.
• Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business and industry trends.
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions.
• Support regional markets with activities related to product being introduced or currently on the market
• Provide support as needed for internal and external audits/inspections

Education and Experience:
Minimum Requirements:

• At least 3 years’ experience in professional writing in a medical technology, life sciences, or healthcare setting
• BA/BS degree
• Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
• knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)
• Ability to organize and judge priorities.
• Ability to assimilate and interpret scientific content, and translate information for appropriate audience in a succinct manner
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills
• Must be fluent in speaking and writing in English
   

Preferred Skills and Competencies:

• Willingness to pursue additional learning and build qualifications in professional field, as required.
• Experience leading/managing improvement projects.
• At least 5+ years of overall work experience in a technical and/or quality/compliance discipline/regulated industry

Physical Requirements (if applicable):          
 

• none

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote  

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