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Medical Compliance Specialist

Company: Apex Systems
Location: San Antonio
Posted on: February 25, 2021

Job Description:

Medical Compliance Specialist Apex Systems is looking for a Medical Compliance Specialist to join their team local to San Antonio. This role will be REMOTE, but will require you to work on site as things open back up after the pandemic. M-F, 8 AM to 5 PM. If interested, please submit your resume to Job Summary: The Medical Compliance Specialist I (MCS I) prepares and maintains adverse event files and compiles adverse event investigation information. The MCS I investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required. The MCS I maintains Regulatory databases and files. The MCS I plays a vital role in the preparation of various regulatory documents such as Medical Device and Vigilance reports. Principle Responsibilities:

  • Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals.
  • Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion.
  • Manages and maintains adverse event files and MDR (Medical Device Report) tables.
  • Creates, organizes and manages regulatory files and documentation including Food and Drug Administration (FDA) submissions, international submissions, annual reports, and ad hoc reports.
  • Conforms to and enforces KCI policies and procedures as related to job function.
  • Performs a role in corporate, departmental, and regulatory audits to record activities as may be deemed suitable and assigned by management.
  • Participates in other duties as assigned. Minimum Qualifications:
    • Associates Degree in Nursing required. Ideally a Bachelor of Pre-Medicine degree or Bachelor of Science degree in Nursing.
    • A minimum of 1 year of experience with advanced wound care therapeutics product/process knowledge. Other Qualifications:
      • Experience in the medical profession or regulatory risk management
      • Excellent computer skills including use of Microsoft Office business software and search engines
      • Excellent oral communication skills
      • Excellent medical/technical writing skills
      • Ability to use/create databases, spreadsheets and prepare documents.
      • Proficiency with Microsoft Office business software and use of information databases
      • Keyboarding skills - > 35 WPM
      • Ability to use databases and prepare documents
      • Proven ability to work and maintain a positive environment with peers, management, all employees and customers
      • Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business and medical judgement
      • Proven ability to communicate effectively, orally, and in writing Preferred Qualifications:
        • Experience with global medical device regulations and compliance standards
        • Preference dealing with diverse groups including medical professionals at all levels
        • Knowledge/experience in quality control, quality assurance, and risk management preferred
        • Ability to work individually and as part of a team
        • Ability to work effectively with all employees and external business contacts while conveying a positive attitude EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice

Keywords: Apex Systems, San Antonio , Medical Compliance Specialist, Healthcare , San Antonio, Texas

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