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Compliance and Product Documentation Analyst

Medical Informatics Corp

Medical Informatics Corp

IT, Product, Legal
Posted on Friday, May 3, 2024

Job Purpose

The Compliance and Product Documentation Analyst is responsible for authoring, formatting, tracking, storing, reviewing, updating, and maintaining control over documentation for Legal & Compliance and Engineering & Tech departments. These documents include policies, procedures, work instructions, forms, records, training slides, etc. The individual is responsible for maintaining Engineering & Tech’s design and product development documentation, including documentation for MIC’s products, ensuring compliance with internal policies, procedures, industry standards, and regulations. This position acts as an information source for quality and compliance-related issues for the Engineering and Tech. Dept. They will lead with an attitude that promotes a culture of quality and compliance, supportive of collaboration, accountability, and innovation.

Duties & Responsibilities

Product Development Compliance Duties

  • Create and maintain software product development life cycle documentation, including software product descriptions, product user manuals, product labeling/indications for use, bill of materials, software requirements specifications, and implementation documentation in partnership with Engineering & Tech software development engineers.
  • Track quality system documentation through the software product development life cycle, including preparing meeting minutes for design reviews, document change orders and updates, and revising product documentation and forms as needed.
  • Maintain responsibility for Device Master Records (“DMR”) and Design History Files (“DHF”) at the close of each product project and audit project folders to ensure all the required documentation has been completed and is readily available within the eQMS.
  • Assist the Engineering & Tech Dept. to create and maintain internal standard operating procedures, work instructions, and corresponding quality system documentation. All documents must align with company document control procedures to maintain consistency by utilizing authorized templates and controlled documents.
  • Function as an information source to Engineering and Tech and Product departments when quality issues arise.

General Compliance Department Duties

  • Act as a Subject Matter Expert (“SME”) for implementation of the electronic Quality Management System (“eQMS”), specifically the Projects and Risk Management Modules and serve as the main point of contact when it relates to training and roll-out to the Engineering & Tech teams.
  • Assist in investigation and resolution of non-conformances and complaints and the resulting documentation within the eQMS.
  • Assists in product validation and verification testing for new version release sprint testing.
  • Assist in the management of corrective and preventive actions (CAPA), perform investigations, root cause investigations, corrective action plan and implementation, and effectiveness verification plan and implementation.
  • Assist in the execution of internal and external audits by preparing comprehensive audit documentation related to process validation and findings, maintaining files, and retrieving requested documents during audits.
  • Effectuate cross-department communication to ensure audit findings are timely addressed and rectified to maintain compliance with regulation requirements.
  • Follow regulatory, industry standards, and cGDP guidelines at all times.
  • Work in conjunction with the Director of Compliance to assist in the development of special department projects.
  • Perform other Legal & Compliance or Engineering & Tech duties as assigned.
  • 5% travel required.

Note: The above statements are intended to describe the general nature and level of work performed by this position. This is not an exhaustive list of all responsibilities.

Required Skills

  • Bachelor of Computer Science or Engineering or Technology, Technical Writing related field or equivalent
  • 2 years of work experience in medical device industry
  • 2 years experience with ISO 13485: 2016, ISO 14971: 2019, 21 CFR 820 regulations.
  • 2 years of work experience with Software Product Development Technical Writing.
  • Experience participating in internal and external audits
  • Excellent writing and verbal communication skills
  • Excellent organizational skills with a high level of attention to detail
  • Excellent time and project management skills
  • Comfortable learning and using new technologies - GitHub, Confluence, Greenlight Guru (eQMS), Smartsheets, and G-suite.
  • Ability to multitask during design reviews, adequately taking notes as needed and making document edits as necessary
    • Ability to self-initiate and work independently on projects
    • Ability to manage multiple concurrent projects from initiation to completion
    • Ability to edit and proofread colleagues' work
    • Ability to generate content on technical topics
    • Ability to actively and effectively collaborate with team members and across departments

Preferred Skills

  • Professional certification in Quality, Compliance, or Regulatory Affairs is a plus.
  • Experience in preparing FDA 510(k) applications for software as a medical device.
  • Experience with Greenlight Guru (eQMS platform), Github and Smartsheet.
  • Demonstrate a basic understanding of computer software product development.

Working conditions

  • If remote-based, availability to travel to Houston no less than three times per year for company or team events
  • Prolonged hours in front of a computer screen
  • Able to work extended hours periodically to meet release deadlines and/or to implement rapid solutions

Physical requirements

  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times

Direct Reports