Regulatory Registration/Reimbursement Intern
About The Position
The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients, and their care teams harmoniously monitor, manage, and protect life. The ASSURE system is a proven approach to sudden cardiac arrest protection. It includes the ASSURE WCD, the ASSURE patient app and the Kestra CareStation remote patient data platform, all working together as a digital healthcare system. It is Kestra’s intention to obtain CE mark for the ASSURE system, making it eligible for distribution in the European Union (EU). A gap analysis defining the Kestra quality system requirements necessary to apply for EU Medical Device Regulation 2017/745 (MDR) approval has been previously conducted. Several EU-centric quality system procedures have been incorporated into Kestra’s quality manual. However, additional work in finalizing second-level work product is required – particularly in the preparation, documentation and support of pre-market application and approval processes. The intern is required to train to portions of Kestra’s current USA FDA- and EU-regulated, industry-compliant quality system. As a precursor to participating in the CE mark process, the intern may train and participate in US FDA postmarket surveillance reporting, trending and risk management. This is a part-time summer internship position (less than 30 hours a week), working with the Regulatory team at Kestra.
Requirements
- Currently pursuing a degree in Regulatory Affairs, Healthcare, Economics, Public Policy, Business, or a related field.
- Strong research and analytical skills.
- Excellent written and oral communication skills and teamwork abilities
- Ability to work independently and manage time effectively.
- Must be enrolled in an accredited college/university taking at least one class in the semester/quarter (spring/fall) prior to participation in the internship program OR must have graduated from a college/university within the past 6 months
- Must not have completed one year of continual employment with Kestra Medical Technologies
- Must be at least 18 years of age
- Must possess unrestricted work authorization
- Must provide own transportation to/from work
- Must successfully complete and pass a criminal and employment background screening that meets the allowable FDA requirements and is in accordance with EEOC rules and regulations
- Must successfully pass a pre-internship drug screen
Responsibilities
- Learning and executing FDA-specific pre- and post-market compliance activities
- Identification of activities supporting the import, distribution and recovery of CE-marked systems intended for deployment in Ireland
- Assessment of cybersecurity and data protection processes associated with personal health data captured by the ASSURE system and made available to a patient’s EU healthcare professional
- Assist in preparing reports and presentations on regulatory and reimbursement topics.
- Ensure compliance with Kestra Quality System, the U.S. FDA Code of Federal Regulations, ISO 13485, ISO 14971 and other International Quality Standards as appropriate.
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What This Job Offers
Job Type
Part-time
Career Level
Intern
Number of Employees
101-250 employees
