Job Details

Level
Experienced

Job Location
Phoenix, AZ - Phoenix, AZ

Position Type
Full Time

Travel Percentage
Negligible

Job Category
QA - Quality Control

Description

Position Summary

This position focuses on global regulatory support and complaint management for in vitro diagnostic devices. This role will provide technical and administrative regulatory for complaints in all global regions. Individual will also work very closely with the customer support team. This is an integral position in team collaboration for global expansion success.

Job Responsibilities

• Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.)
• Ensure accurate documentation of evaluation and investigation result of the complaint file; including literature files, and clinical files.
• Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia and close files appropriately within 60 to 90 days to meet metrics.
• Responsible to assess and review additional information and make MDR determination based on the additional information received. Interact with Manufacturing site by requesting DHR when lot is provided (Device History Record). Request Sample retrieval for analysis.
• Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
• Process additional information and recommend and make changes into the file based on the additional information received.
• Evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
• Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, and Technical Services.
• Good understanding of basic principles, theories, concepts and techniques related to customer complaints.
• Ensure compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Health & Safety Practices, and other applicable standards as pertaining to medical devices.
• Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Good knowledge of international standards and regulatory requirements, including, but not limited to ISO 13485 and 21 CFR, section 803 and 820. Responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
• Review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world.
• Ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting.
• Applies Confidential practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
• Applies Confidential practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
• Assists with the summary reporting for the US FDA. Responsible for updating files with new information into the ECM tool, asses that new information to determine what needs immediate attention, malfunction reporting, regulatory reporting and assisting with the final review of a triage of files before the case can be closed.

Required Qualifications

• B.S. / B.A or equivalent in related scientific field.
• 3-5 years of professional regulatory experience with medical devices, IVDs, or related field.
• Knowledge and experience with regulatory requirements for IVDs.
• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification. Also, individual must be fully vaccinated for COVID-19 by the date of hire to be considered for U.S.-based jobs, if not currently employed by Caris Life Sciences.

Core Skills & Competencies

• Demonstrated success independently working with cross-functional teams.
• Strong Communication, interpersonal and problem-solving skills and detail oriented.
• Drive for Results (Service, Quality, and Continuous Improvement) - Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
• Communication - Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Ability to compose clear, concise, and professional written communication.
• Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
• Customer Service Focus - Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this position.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

*Interested parties please email your resume to Tonia Hunter @ [email protected]. #LI-TH1

Qualifications