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Product Surveillance Tech
Ref No.: 19-11038
Location: Austin, Texas
Sunrise System Inc. is currently looking for Product Surveillance Tech in Austin, TX with one of our top client.
 
Job Title: Product Surveillance Tech
Job Id: 19-11038
Location: Austin, TX 78753
Duration: 4 Months
Position Type: Hourly contract Position (W2 only)
 
Job Summary
  • Under general direction, the Product Surveillance Representative I will perform a variety of complex duties associated with supporting current and potential patients of various Post Market Clinical Studies and Commercial Products.
  • The Commercial Product Surveillance Representative will investigate and maintain complaint files and determine report ability in compliance with regulations established by the FDA and international regulatory bodies.
  • In addition will process claims for financial reimbursement and replacement products in accordance with Client's reimbursement policy.
  • "The employee must conduct their work activities in compliance with all Client internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971.
  • Client internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.”
Key Duties and Responsibilities: Describe Scope: % of Time or Importance
  • Investigate and maintain complaint files, following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make decisions for report ability under
  • MDR regulation, 21 CFR 803 and international regulations.
    Initiate and set up complaint files. Maintain and update database.
  • Record all complaint activity in both hard copy (when applicable) and computer files. Conduct regulatory reporting in accordance with applicable regulations, Retrieval Program, and internal trending.
  • Make report ability decisions within specified timelines.
  • Assess incoming documentation for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis.
  • Interface with device analysis lab regarding analysis results and processing complaints.
  • Review adverse events reported in clinical studies to determine if events meet the regulatory definition of potentially reportable event or complaint.
  • Initiate Further Investigation, and any additional follow-up and communication pertinent to the MDR as needed.
  • Track files sent to Quality Assurance for Further Investigation and complete necessary documentation.
  • Evaluate Further Investigation results, summarize findings, and determine and document the conclusion(s).
  • Maintain a knowledge and understanding of current MDR regulations, MDR guidelines, MDR interpretations, product labeling, other federal laws governing medical devices, Department of Transportation (DOT) requirements for explant returns, and the FDA mandated Retrieval Program 60%
Process Support
  • Process outgoing faxes, incoming mail, perform data entry, filing and copying.
  • Inform patients and doctors of product return requirements.
    Ability to identify potentially litigious customers, and forward to management for resolution.
  • 10% Provide generalized company, departmental and product knowledge as required.
  • Handle patient inquiries about clinical studies from internal and external customers.
  • Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operations, Marketing departments, and Client manufacturing facilities.
  • Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing "talking points” and communicating corporate policy. 15%
  • Initiate and process product reimbursement and claim records.
    Inform internal and external customers of Client's reimbursement policy and product return requirements.
  • Contact internal and external customers if claim is incomplete. Ability to monitor several cases at once, including status and follow-up as necessary.
  • Respond to verbal and written requests from internal and external customers for payment of warranty in a timely manner.
  • Ability to identify potentially litigious customers, and forward to management for resolution. 10%
  • Support the department on special projects as needed. 5%
Job Qualifications (Minimum Requirements)
  • The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Education and Experience
  • AA degree; Bachelor's degree is preferred.
  • 2-3 years’ previous experience in customer service or clinical setting; or equivalent combination of education and experience.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
  • Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to use word processing, spreadsheet, and database applications.
  • Ability to learn various software programs.
  • Ability to handle confidential data in accordance with HIPAA and related international standards.
  • Ability to function in a controlled environment regulated by the FDA and other regulatory authorities
  • The specific requirements include but may not be limited to: Knowledge of current MDR regulations, guidelines, and interpretations.
  • Vigilance reporting as prescribed within EEA, EAME, APAC and LATAM regions. Includes Council Directive 93/42/EEC June 1993 (Medical Device Directive) and other country/regional medical device regulation.
  • Expertise of any transpositions by countries within the EEA.
  • Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures).
  • ISO 13485:2016, ISO 14971, the Canadian Medical Device Regulations 1998, SOR/98-282, and the
  • Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.
  • Knowledge of clinical, surgical techniques and procedures, and medical terminology.
  • Skill in demonstrating a professional phone manner.
  • Effective communication with physicians and nurses as required.
  • Expertise in complaint policies and requirements.
  • Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts
  • Ability to learn about Client Medical's products and procedures/techniques associated with their use.
  • Ability to take initiative and make decisions.
  • Ability to accurately perform detail-oriented work.
  • Ability to be flexible in changing daily workload priorities as directed.
  • Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment
  • Ability to participate in multiple projects.
  • Ability to manage a high-volume case load.
  • Ability to think critically and analytically to evaluate each record on a case-by-case basis.
Contact
Rahul
Direct: (732) 272 0347| Email: Rahul.R@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com