Regulatory Registration/Reimbursement Intern at Kestra Medical Technologies, Inc

Kirkland, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

25.0

Posted On

11 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, FDA compliance, Quality systems, Risk management, Data protection, Cybersecurity, Research, Analytical skills, Technical writing, Communication, Teamwork, Time management, ISO 13485, ISO 14971, Post-market surveillance

Industry

Medical Equipment Manufacturing

Description

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. ESSENTIAL DUTIES 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. COMPETENCIES Integrity: Commitment, accountability, and dedication to the highest ethical and legal standards. Collaboration/Teamwork: Interface with Kestra personnel regardless of geography, position, or experience. Action/Results: High energy, observant to detail, timely execution. Innovation: Generation of new ideas and/or improvements from original thinking. Customer Focus: Quality of work, services, and experience always present of mind. Emotional Intelligence: Recognizes, understands, manages one’s own emotions and can influence others. QUALIFICATIONS Education/Experience Required: 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. WORK ENVIRONMENT Indoor open office environment Minimal noise volume typical to an office environment Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment, post-offer. INTERNSHIP ELIGIBILITY 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 PHYSICAL DEMANDS Repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage Frequent stationary position, often sitting for prolonged periods of time Frequent computer use Occasional lifting up to 20 pounds OTHER DUTIES This position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Intern. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. PROGRAM LENGTH The approximate dates of this summer internship are May 2026 through August 2026 with the understanding that not all higher education academic calendars will fit the entire range. Interns must be available to work for the duration of the internship time period agreed upon at the time of interview. Pay: $25.00/hour Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, disability, age, sexual orientation, gender identity and/or expression, marital status, or any other characteristic protected by law. Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided. If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted. We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S. Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment This role is an in-office position Monday - Thursday, in Kirkland, Washington with the flexibility to work from home on Fridays.

Responsibilities

The intern will assist with FDA-specific pre- and post-market compliance activities and support the import and distribution of CE-marked systems. They will also assess cybersecurity processes and prepare reports on regulatory and reimbursement topics.