Job Description

About the Role: We are looking for a Regulatory Operations Associate to join our team. In this role, you will provide direct support to the Regulatory Affairs function through submission publishing and other activities where centralized expertise promotes efficiency, consistency, and compliance to policies and regulations.

This position offers multiple work arrangements: on-site at our facility in Flagstaff, Arizona, hybrid or fully remote work allowed in most locations within the United States, depending upon the responsibilities of the role and business needs.

Responsibilities:

• Provide publishing support for global regulatory submissions, including formatting, PDF compilation, and template development
• Manage simultaneous priorities in support of Regulatory Affairs activities
• Develop, improve, and work within standard operating procedures (SOPs) and work instructions to promote consistency and compliance
• Assist in the maintenance of data and documentation related to global regulatory submissions, including verification, systems input, and the generation of reports
• Ensure proper electronic and/or paper storage of regulatory submissions, government approvals, and other related information
• Perform other support activities for regulatory submissions, such as obtaining certificates from the FDA and fulfilling requests for legalized documents, etc.
• Collaborate with global regulatory affairs associates to ensure compliance to functional initiatives and to ensure proper support for associates related to those initiatives

Required Qualifications:

• Bachelor\xe2\x80\x99s Degree or minimum 3 years experience working in a regulated industry with a positive track record
• Demonstrated superior attention to detail
• Demonstrated superior English oral and written communication skills
• Demonstrated ability to quickly learn new systems and processes
• Expertise in Word, Excel, and Adobe Acrobat
• Ability to travel up to 10%

Desired Qualifications:

• Direct experience with Regulatory Affairs documentation and processes
• Direct experience developing SOPs and training personnel
• Experience with business process development

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore\xe2\x80\x99s 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 \xe2\x80\x9cprofit-sharing\xe2\x80\x9d. Learn more at

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

#LI-Remote

#LI-MSL

W. L. Gore & Associates