Sr. Regulatory Affairs Specialist (Contract)

Precision Life Sciences - Eden Prairie, MN

Summary:

The Senior Regulatory Affairs Specialist will execute regulatory activities to support currently marketed devices and new product development. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.

 

Responsibilities:

  • Ensure Establishment registrations (FDA) and international registrations and licenses remain up to date
    • Interface with agents to support product registrations/licensing for various international markets
    • Global Product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies

       

  • Research, renew and obtain State Licensing needed for products.
    • Drive Labeling and Copy review for products for domestic and international markets.
    • Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.
    • Maintain and manage post-market surveillance/post-market clinical follow-up and Clinical Evaluation Reports
    • Prepares U.S. FDA submissions (e.g., IDE, 510(k), annual reports) as required and per applicable SOPs.
    • Reviews Engineering Change Orders, Design Change Notices, and other deviations for compliance with FDA, European and International regulations and standards.
    • Support product development projects, maintain DMRs, Technical files, Design Dossiers, etc.
    • Support Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs)
    • Assist in the preparation and execution of Field Action activities.
      • Ensure adequate documentation of compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.
      • Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and BDPI Notified Body.
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        Qualifications:

        • Bachelors of Science or technical degree or equivalent experience
        • Regulatory Affairs medical industry or related proven industry experience (medical device, pharmaceutical and/or healthcare), 0-3 years.
        • Excellent written and verbal communication and technical writing skills
        • Strong organizational and interpersonal skills
        • Ability to optimally manage multiple projects with shifting priorities
        • General knowledge of FDA and European medical device regulations, including IDE, 510(k), MDD & MDR beneficial
        • Able to apply independent decision-making and analytical thinking skills
        • Proficiency with PC computers and Microsoft Office software
        • Technical knowledge of wound care products and related medical procedures and associated medical terminology preferred
        • Ability to work independently with minimal direction
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          Preferred Skills:

          • Excellent communication with all levels of internal and external stakeholders
          • Excellent critical thinking and decision making
          • Great organizing
          • Microsoft 365 (Excel, Outlook, PowerPoint, SharePoint, and Word)

             



        Posted On: Monday, November 28, 2022



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