Regulatory Affairs Coordinator

Company: Endologix
Location: Irvine
Posted on: May 25, 2023

Job Description:

Overview
Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.
We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.
With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.
Overview:
The role of the Regulatory Affairs Coordinator is to provide regulatory compliance, regulatory submission, and other system support to the Endologix Regulatory Affairs department
Responsibilities

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• Key Responsibilities:
  
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  • Interface and support team members of Regulatory Affairs department
    
  • Support Device Tracking activities
    
  • Maintain the Regulatory Affairs filing system (both paper and electronic files), Registrations Database, and Literature Library/Database
    
  • As requested by RA management, perform various administrative duties in support of the Endologix Regulatory Affairs department including, but not limited to:
    
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    • Maintaining calendars and schedule/coordinate meetings, appointments, and training
      
    • Maintaining internal trackers to support internal audits and recall activities and interfacing with cross-functional personnel, as required
      
    • Working with external personnel for catering requests to support external audits and other department activities
      
    • Issue purchase orders, process department invoices, and maintain expense files and office supply inventory
      
    • Preparing presentations, scorecard updates, and department organization charts
      
    • Taking and transcribing meeting minutes and follow up actions as required
      
    • Maintain departmental office supplies inventory and weekly orders
      
      
      
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      • Perform other duties as assigned by Regulatory Affairs Management
        
      • Up to 5% travel is anticipated
        
        
        Qualifications
        Qualifications:
        
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        • Minimum bachelor's degree or equivalent experience.
          
        • Minimum -2-5 years of experience in administrative support and/or healthcare activities.
          
          
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          • Ability to develop a working knowledge for relevant medical device regulations and quality systems.
            
          • Must be detail oriented and demonstrate basic technical writing abilities.
            
          • Good interpersonal skills including ability to interact with internal staff and external customers with a high degree of diplomacy.
            
          • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
            
          • Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within internal and external commitment dates.
            
          • Must demonstrate effective problem-solving techniques, critical thinking skills, and basic math skills.
            
          • Effective problem-solving skills
            
          • Strong communication and organization skills required.
            
          • Expertise in Microsoft Office applications and charting programs.
            
            Expected Base Salary: $53,000- $73,250 (Compensation will be commensurate with experience and expertise.)
            At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. We work hard to bring life changing products to patients and believe that a culture which is inclusive of our individual backgrounds and passions will help us create ideas that move all of us forward.
            As a global business, our ability to understand, embrace and operate in a multicultural world - in the marketplace and workplace - is critical to our success. Many employees across the company work diligently to help us advance in our diversity journey. Employee feedback gathered both formally and informally further strengthens our culture of inclusion and collaboration as well as initiatives focused on gender and U.S. ethnicities.
            Join us, and bring your point of view, talents and contributions so we can all grow together.
            

Keywords: Endologix, Irvine , Regulatory Affairs Coordinator, Other , Irvine, California