The incumbent delivers written documentation of safety assessments, supports the response to queries from regulatory agencies in relation to global vigilance reports (including U.S MDR filings), provides technical writing expertise and leadership to the generation of post market safety reports (such as PSUR and CSR), provides clinical/medical input to other post market surveillance activities, and serves on multifunctional teams. This individual will provide support to internal functional teams and groups, such as those responsible for complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, and field actions.
Responsibilities:
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The incumbent will:

• Provide professional support and guidance to the formally designated unit, such as in the areas of global vigilance reporting and technical compliance writing.
• Interact with patients to obtain additional information and provide other support as part of critical complaint follow up.
• Provide written responses to requests for a medical analysis of adverse events, potential or actual reportable events, and/or potential safety signals identified through data trending or complaint evaluation teams.
• Lead and ensure on-time and effective completion of post market safety reports, such as PSUR and Canada Summary Reports, and collaborate with Clinical Affairs and Regulatory Affairs with respect to PMCF, SSCP, literature review, and clinical evaluation. Provide support to these reports that includes an integrated qualitative and quantitative assessment of post market adverse events and interpretation of their medical significance with relevant recommendations.
• Collaborate cross-functionally to write, compile, and/or provide expert input to compliance documentation for post market, such as device PMS plans, HHEs, CAPAs, and field actions.
• 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.
• Acquire and maintain knowledge of assigned products/products and therapies including labeling, indications, populations evaluated, alternative therapies and treatments.
• Partner with other members of RA/QA and provide medical input in the development of field action plans and safety communications; provide guidance to product issue investigation teams to identify events of interest.
• Maintain knowledge of relevant regulations and guidelines in the medical device industry and the broader life sciences/healthcare/med tech ecosystem, including ISO 14971, FDA, MDCG, IMDRF, and ICH guidelines for classifying and reporting medical device and drug adverse events.
• Contribute to the development and implementation of safety program initiatives, process,

improvements, and sound safety principles and practices.
Education and Experience:

Minimum Requirements:

• Minimum of 5 years’ experience in Quality Assurance, Regulatory Affairs, Medical Device engineering and development, Post Market Surveillance, and/or Medical/Clinical/Patient Safety in a medical technology, life sciences, or healthcare setting.
• At least 3 years’ experience in professional writing in a medical technology, life sciences, or healthcare setting.
• At least 3 years’ work experience specifically in clinical risk management or post market safety.
• BA/BS degree in healthcare discipline, engineering
• Competence in Microsoft Office programs (e.g., Word, Excel, and PowerPoint)
• Ability to assimilate and interpret scientific content and translate information for appropriate audience in a succinct manner.
• Ability to quickly learn new technologies.
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills

Preferred Skills and Competencies:
BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.
Experience in diabetes medical device engineering
Physical Requirements (if applicable):
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None

• 10% travel may be required

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $84,975.00 - $127,462.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), 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 tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. 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. For more information, please visit insulet.com and omnipod.com.
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!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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