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.
This position is accountable for supporting Quality activities associated with complaint handling and MDR/Vigilance submissions. Performs activities within the overall post market surveillance program, including processing of product feedback and complaints. These activities focus on the process for global medical device reporting to competent authorities and includes review and evaluation of quality complaints for fielded product which may represent reports of adverse events and/or critical device malfunctions and timely processing of the reports adhering to global regulations and standards. Interface with cross-functional departments.
This role is an in-office position Monday - Thursday, with the flexibility to work from home on Fridays.
ESSENTIAL DUTIES
Maintain Complaint handling and post-market surveillance systems.
Handle the processing, monitoring, and reporting of product defect complaints.
Daily review of reported complaints and/or returns for trending and identification of potential regulatory reporting and corrective / preventive actions.
Generate Adverse Event and Vigilance Reports specific to applicable countries and ensure supplements are filed in a timely manner with appropriate follow-up and complete and accurate reporting. Escalate adverse events to Kestra leadership team, as needed.
Document product complaints in database for trending and analysis and ensure the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion.
Prepare complaint responses to customers and commercial teams as necessary per process and at the direction and oversight of the VP of QA / RA.
Perform required activities as assigned in field notifications / actions or recalls, regulatory agency notifications, and/or agency submissions for clearance to market products in markets of entry.
Correlate complaint reports, failure analysis reports, and adverse event reporting with complaint data for investigation and determine required actions.
Interface with Customer Care and field team members to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and/or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked.
Apply knowledge of device regulatory requirements to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting.
Partner with other departments to resolve product problems and provides feedback to Customer Care and/or customers as needed.
Assist with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.
Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Ensure compliance with Kestra Quality System, the U.S. FDA Code of Federal Regulations, the European Medical Device Regulation, ISO 13485, ISO 14971 and other International Quality Standards as appropriate.
COMPETENCIES
Action/Results: Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities to agreed upon timelines.
Passion: Contagious excitement about the company - sense of urgency. Commitment to continuous improvement.
Integrity: Commitment, accountability, and dedication to the highest ethical standards.
Innovation: Generation of new ideas from original thinking.
Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
Emotional Intelligence: Recognizes, understands, manages one's own emotions and is able to influence others. A critical skill for pressure situations.
Analytical Thinking - Approach problem-solving by using a logical, systematic, sequential approach with the ability to work on problems of a diverse nature in which analysis of data requires evaluation of identifiable factors is required
Diagnostic Information Gathering - Identify information needed to clarify a situation, seek that information from appropriate sources, and using skillful questions to draw out the information.
Thoroughness - Ensure that one's own and other's work and information are complete and accurate; careful preparation for meetings and presentations; following up with others to ensure that agreements and commitments have been fulfilled.
Fostering Teamwork - As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
Interpersonal Awareness - Noticing, interpreting, and anticipating others' concerns and feelings, and communicating this awareness empathetically to others.
Influence Skill - Gaining others' support for ideas, proposals, projects, and solutions.
Building Collaborative Relationships - Developing and maintaining partnerships with others.
Oral and Written Communications - Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration.
Persuasive Communication - Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
Requirements
QUALIFICATIONS
Education/Experience Required:
Bachelor's degree or equivalent experience in technical environment.
Minimum 3 years of Regulatory and Quality experience in an FDA regulated industry and technical environment.
Experience interacting with U.S. FDA electronic databases (e.g., MDR eSubmitter) or other government databases is required
Ability to read, analyze and comprehend (in English) complex instructions, correspondence, technical memorandums, and clinical and medical articles. Documents may include government regulations, work orders, work instructions, product manuals, policies and procedures, peer reviewed papers, etc.
Thorough understanding of FDA and international medical device regulations
Hands on knowledge of medical device reporting and post-market surveillance.
Proven ability to work with minimal guidance from management to perform job function
High level of computer proficiency with expertise in Microsoft Office applications, spreadsheets, data trending, and charting programs required.
Ability to work well in a cross-functional setting
Bachelor's degree in engineering, life sciences, regulatory or equivalent technical field.
A Regulatory Affairs Professional Society [RAPS] Regulatory Affairs Certification [RAC] or advanced equivalent is strongly preferred.
Previous experience with Class III medical devices.
Working knowledge of fundamental quality and statistical tools
Preferred:
Bachelor's degree in engineering, life sciences, regulatory or equivalent technical field.
A Regulatory Affairs Professional Society [RAPS] Regulatory Affairs Certification [RAC] or advanced equivalent is strongly preferred.
Previous experience with Class III medical devices.
Working knowledge of fundamental quality and statistical tools
WORK ENVIRONMENT
This role is in our Kirkland offices and you must live in the Washington Area.
Indoor open office environment
Minimal noise volume typical to an office environment
Extended/overtime hours when needed
Drug-free
PHYSICAL DEMANDS
Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
Frequent stationary position, often standing or sitting for prolonged periods of time
Frequent computer use
Frequent phone and other business machine use
Occasional lifting required, up to 20 pounds
TRAVEL
Occasional travel, domestic and international, may be required, less than 10%
OTHER DUTIES:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Benefits
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.
Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.
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.
Salary: Annualized at $85,000 - $95,000, plus bonus. Depending on experience.
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.
