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Regulatory Leader, Intelligence and Standards Management

Company: W.L. Gore & Associates
Location: Phoenix
Posted on: April 2, 2024

Job Description:

About the Role: We are looking for a passionate, engaged, and proactive leader to join our Regulatory team. In this role, you will lead the Regulatory Intelligence and Standards Management teams.

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

Responsibilities:

  • Provide leadership to Regulatory Intelligence and Standards Management associates
  • Ensure the execution of the Medical Products Division's Regulatory Intelligence and Standards Management processes, ensuring alignment of priorities and coordination with the Business Groups
  • Broadly communicate Regulatory Intelligence to create awareness to applicable new and changing regulatory requirements and facilitate adoption into Regulatory Strategies and/or Gore MPD's Quality System
  • Routinely interact with Quality, Regulatory, Engineering, Technology, and other leadership teams to help maintain a balanced perspective on Standards Management priorities and strategic areas for external focus
  • Monitor Regulatory Intelligence and Standards Management process performance and coordinate with other functional teams to identify and implement opportunities for improvement
  • Contribute to and coordinate external engagement activities, including maintaining relationships and interfacing with applicable government agencies, trade associates, and standards organizations
  • Exhibit role model behavior consistent with our culture and leadership practices in support of our brand promise of Together, Improving Life
  • Maintain compliance with training expectations as required for this position
  • Additional responsibilities as required within the scope of this position
  • Establishes clear expectations of equitable and inclusive behaviors from Associates and acts immediately to appropriately address negatively impactful or unfair behavior

    Required Qualifications:
    • Bachelor's degree in biological, chemical, engineering, medical, legal, or allied health sciences field
    • At least 5 years of experience working in a medical-device and/or pharmaceutical industry role directly involved in the application of regulations and standards
    • Experience engaging with and influencing regulatory agencies, trade associations and/or standards organizations
    • Experience leading complex projects or diverse teams
    • Knowledge of global regulatory processes including FDA and EU submission requirements
    • Strong communication skills (oral, written, and interpersonal) adaptable to circumstance and audience
    • Success working across multiple geographies including, but not limited to, the U.S., Europe, Japan, and China
    • Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
    • Ability to travel as necessary domestically and internationally to achieve business and project objectives

      Desired Qualifications:
      • Advanced degree in a biological, chemical, engineering, medical, legal, or allied health sciences field
      • Regulatory Intelligence process experience

        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

        #LI-MSL

        #LI-Remote

Keywords: W.L. Gore & Associates, Phoenix , Regulatory Leader, Intelligence and Standards Management, Executive , Phoenix, Arizona

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