Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Irvine, California
CLINICAL FIELD ASSURANCE SPECIALIST
Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.
Job Scope and Purpose:
This position is responsible for providing clinical/medical insight and guidance into the customer complaint handling process for the purpose of ensuring compliance with US and international regulatory compliance and complaint handling/device reporting requirements. This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.
* Responsible for the review, analysis, and summation of medical records and images (e.g., CT) provided in conjunction customer complaints, for inclusion into investigational reports for primarily non-escalated case events.
* Recognition and confirmation of reported and unreported failure modes, as observed in medical records or imaging studies.
* Utilizes department software to document expected clinical results.
* Supports the Adjudication process, as needed (report writing, meeting preparation, etc.)
* Participation in the decision making, development, and/or review process related to Medical Device Reporting (MDR) and/or Vigilance or other international reporting.
* Collaborates with Patient Safety Director as needed or as requested.
* Supports regulatory body interface related to inquiries associated with adverse event reporting.
* Provides clinical and technical assistance and training of other Field Assurance department employees.
* Supports Principal Clinical Field Assurance Specialist with activities related to new and revised labeling, risk management, quality management, and both internal corporate and external audits, and other projects as needed.
* Perform other duties as assigned by Principal Clinical Field Assurance Specialist, Field Assurance Department manager or supervisor.
* Registered Nurse (RN) or other applicable clinical/medical license or degree.
years of related work experience, including:
* Minimum of 3 years of medical device experience (Class II/III) or a combination of clinical and medical device experience and a minimum of 5 years of other experience in a medical field.
* Some knowledge with regulatory reporting, quality systems and relationship to business.
* Ability to facilitate and provide leadership concerning investigational activities.
* Must demonstrate technical writing ability.
* Good interpersonal skills including ability to interact with high degree of diplomacy.
* Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
* Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
* Effective problem solving techniques and excellent applied thinking skills.
* Strong communication and organization skills required.
* Expertise in Microsoft Office applications and charting programs.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
* Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
* Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
* Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
* Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
* Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
* Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
* Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
* Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
* Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
* Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
* Computer Skills: Software proficiency in Microsoft Office Suite.
* Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
* Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
* Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global