Regulatory Affairs Operations Associate

Company: W.L. Gore
Location: Flagstaff
Posted on: September 19, 2023

Job Description:

About the Role: We are looking for a Regulatory Affairs Operations Associate to join our team. In this role, you will provide data governance, maintain information systems, and implement change management and process improvement in support of market access.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:

• Establish, enforce, and audit data governance policies, standards, and procedures for regulatory data to ensure consistent and accurate information
• Maintain regulatory information systems and databases, ensuring timely updates and accurate documentation
• Collaborate with regulatory affairs professionals to collect, review, and validate data required for regulatory submissions, approvals, and compliance
• Generate reports and provide insights to regulatory affairs teams, management, and relevant stakeholders to support decision-making processes
• Collaborate with regulatory affairs professionals to identify data needs and provide support for regulatory submissions and approvals
• Conduct training sessions and offer guidance for regulatory affairs teams to promote data governance best practices and improve data literacy
• Assist in the implementation of new regulatory processes, systems, and requirements, ensuring seamless data integration and compliance
• Utilize project management tools and systems to track project progress, identify potential risks or delays, and implement necessary corrective actions Required Qualifications:
  
  • Bachelor's Degree or a minimum of 3 years experience working in a regulated industry with a positive track record
  • Direct experience with Agile or equivalent Product Lifecycle Management System
  • Direct experience with quality system processes (e.g., Change Orders, Corrective and Preventative Actions, Observation Reports)
  • Direct experience with Regulatory Affairs documentation and information
  • Experience with Standard Operating Procedure development, associate training, and business process development
  • Demonstrated superior attention to detail
  • Demonstrated superior English oral and written communications skills
  • Demonstrated ability to quickly learn new systems and processes
  • Ability to travel up to 10%
    Desired Qualifications:
    
    • Bachelor's Degree (Information Systems or related field preferred)
      This position requires access to export-controlled areas and information. Candidates must be "U.S. persons" as that term is defined in 8 USC -1324b(a)(3). The term "U.S. persons" includes resident aliens ("green-card" holders) as well as certain refugees, asylum-holders and residents qualifying for temporary residence under the terms of 8 USC -1255a.
      
      Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
      
      What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
      
      We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits
      
      We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
      
      Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
      
      Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
      
      Additional Information
      
      • Travel%: 10%
      • Shift: Day Job
      • Schedule: Full-time
      • Posting Date: Sep 8, 2023
        About Gore
        
        For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible - not just through our products and technologies but also through individual growth and development.

Keywords: W.L. Gore, Flagstaff , Regulatory Affairs Operations Associate, Other , Flagstaff, Arizona