Position Overview:

Responsible for the review, analysis, and responses to regulatory agencies regarding medical device reportable events.

Collaborate both within post market surveillance and across other functions, including quality, clinical, Customer Care and regulatory to help ensure compliance with reporting requirements and good documentation practices.

Manages internal and external communication related to post market surveillance

Provide overall support on vigilance and quality and regulatory subjects as required

Responsibilities:

·        Sending Insulet communications to prestataires and HCP regarding customer care, warranty and materiovigilance

·        Main point of contact for prestataires on all materiovigilance matters

·        Oversees the volume and trends of warranty replacements (status update - 1st line)

·        Coordinate the update of complaint cases with the technical writers and customer care teams as necessary

·        Create and provide analysis on complaints reports

·        Communicating investigation results to prestataires

·        Lead overall process of response to competent authorities requests for additional information on reported cases

·        Reports all incidents or risks of incidents related to the use of the Omnipod device of which they are made aware of, as set out in the current procedures.

·        Support audits as required

·        Complete regulatory review and validation of material intended for use with third parties

·        Keep informed of state of the art

·        Performs other duties as assigned

Education and Experience:

·        BA/BS degree

·        Experience in medical device or pharmaceutical laboratory (2-3 years).

Skills/Competencies:

·        Relational ease and assertive personality

·        Adaptability and flexibility

·        Demonstrate strong autonomy and accountability

·        Customer service culture

·        French-speaking person, with fluent spoken and written English

·        Knowledge of Windows 10 (Outlook, Excel, etc)

·        Computer knowledge - ideally SalesForce.com

·        Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.

·        Ability to organize and judge priorities with minimal direction.

·        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

Physical Requirements (if applicable):   

·        None

·        Some travel required

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!

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