Insulet Corporation
Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA)
US - Massachusetts, USA · Senior
Sponsorship not specified$92k-$138kDetected 7 hours ago
ExcelClinical TrialsFDA RegulatoryMedical DevicesCommunicationMicrosoft OfficeRegulatory Affairs
About the role
- Position Overview:
- The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering.
Responsibilities
- Partner with Marketing and Development teams to provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
- Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.
- Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance.
- 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.
Requirements
- Knowledge of regulatory guidelines and requirements (domestic and international).
- Compile and submit documentation as required in support of marketing initiatives.
- Prepare submissions and reports for FDA and support other international agencies as required.
- Performs other duties as required.
Nice to have
- RAC Certification preferred.
- Preferred Skills and Competencies:
Skills
- Effective verbal and written communication skills
- Experience with reviewing ECOs, Requirements, and Specification Documents.
- Understanding of 21 CFR 820, CMDR, ISO 13485, MDD.
- Ability to communicate at multiple levels of an organization.
Compensation
- Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $91,700.00 - $137,525.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:
Company info
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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