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.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
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:
- Previous experience required 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.
- Strong previous experience 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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Top Skills
What We Do
Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod® Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
