RA Specialist

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Imbed Biosciences, Inc

RA Specialist

Middleton, WI
Full Time
Paid
  • Responsibilities

    Are you passionate about building and creating things? Do you crave the satisfaction that comes from knowing that the work that you do every day is important and making an impact on the lives of patients around the world? Are you an excellent communicator and team member? If so, then we want you on the Imbed Biosciences team!

    Job Title: RA Specialist- Medical Device

    Location: Onsite, Middleton, WI

    **Reports To: **Director of Quality

    Job Type: Full-Time

    Department: Quality/Regulatory

    Job Summary:

    This position is responsible for managing the company's eQMS (Electronic Quality Management System. Maintaining a compliant change control process within the eQMS and supporting effective Employee Training.

    This position is responsible for supporting Internal and External Functional Teams in the areas of Facility Registration, Product Listing, International Product Registration and Promotional Materials.

    Responsibilities:

    • Maintain and improve processes associated with the company’s eQMS, ensuring timely completion and version control of all new and revised documentation.
    • Responsible for overall coordination of controlled documents within the company's Document Control system.
    • Work cross functionally to ensure change orders are executed in a timely manner.
    • Ensure accuracy and consistency of documentation per approved Standard Operating Procedures.
    • Perform system-audits and ensure that current revision is available at point-of-use.
    • Co-ordinate training plans and gather/organize complete training documentation.
    • Support user requests for documents.
    • Maintain quality records per applicable SOPs
    • Support the preparation and submission of International Product Registration documentation.
    • Support review of Regulatory Standards, requirements and guidance from Regulatory Authorities.
    • Maintain databases as required and support Regulatory Compliance projects as assigned. (Facility Registration, Device Listings, GUDID, UDI, etc.)
    • Support Internal and External Audits (FDA or Notified Body), assist with coordination of document requests.
    • Other items may be assigned as deemed necessary by Quality Management.

    Required Qualifications:

    • Strong communication (verbal and written) and interpersonal skills.
    • Detail oriented with the ability to accomplish objectives with minimal supervision.
    • Computer Skills: software proficiency in Microsoft Office Suite is required.
    • Minimum of 2 years of experience in Document Management System.
    • Medical Device related certification(s) are a plus.
    • Experience with wound care products is preferred.
    • Travel Required: up to 5%

    Education and Experience:

    • Bachelor’s Degree with a minimum of 3 years of relevant experience in the medical device industry. (Preferably in Quality Assurance or Regulatory Affairs)
    • Experience in cGMP/GDP/GCP environments, ISO 13485, ISO 14971 and FDA 21CFR820.
    • Quality Certifications (CQE, CQA, CQM, RAC) preferred.

    Why You Should Apply

    Imbed Biosciences, Inc. is a growing medical device company with commercial products being sold in the U.S. and overseas, and with many exciting products in the development pipeline. We offer flexibility, excellent salary and benefits, professional growth and development, and a team that will propel you to succeed!

    If you are looking for a place to grow, thrive, innovate, make a difference in patients' lives, and enjoy the work you do, then we want you on the Imbed team!