Global Clinical Affairs Device Specialist (Hybrid) Acton, Massachusetts

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: Global Clinical Affairs Device Specialist

Department: QA Clinical

Manager/Supervisor: Senior Manager, Global Clinical Affairs Data

FLSA Status: Exempt

SOP Group:  Clinical/Regulatory

Position Overview:

The Global Clinical Affairs Device Specialist is responsible for managing all clinical device needs, logistics, and vendor relations for domestic and international studies.

Responsibilities:

• Collaborate with manager to identify and manage device builds based on study design and regulatory requirements
• Calculate number of devices needed based on study design
• Responsible to manage device build timelines to ensure devices are available on time according to overall project plan
• Coordinate cross-functionally with regulatory, quality, and operations to identify and support appropriate labeling of devices
• Collaborate with manager to determine device shipping and logistics based on domestic and international requirements
• Responsible to manage device projections, inventory and site allocations
• Responsible to manage internal device inventory
• Collaborate with manager to establish processes and manage appropriate device deficiency and adverse event reporting for pre-market and post-market studies Responsible to manage all device-related vendor relationships
• Collaborate with manager to identify and manage device needs with partners both internal and external to Insulet
• Performs other duties as required.

Education and Experience:

• Bachelor’s degree and/or an equivalent combination of education or experience.
• Minimum of 2-5 years of relevant experience in the field.
• Must have analytical skills, be detail-oriented, and have good interpersonal skills. Knowledge of agency guidelines and requirements.

Skills/Competencies:

• Excellent written and effective verbal communication skills.
• Ability to communicate cross-functionally across the organization.
• PC skills; word processing, spreadsheet, database, Internet search and utilization.
• Flexible and able to work in a fast paced environment.
• Team player.
• Ability to organize and judge priorities.
• Excellent ability to generate and maintain accurate records

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). ## LI-hybrid

Additional Information:

The US base salary range for this full-time position is $74,000.00 - $111,200.00. 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.