Senior Regulatory Affairs Professional

Job Description Senior Regulatory Affairs Professional Req Id: 2053 State/Province: Arizona Business: Gore Medical Products Category: Clinical & Regulatory Sub-Category: Regulatory & Quality Work Arrangement: Remote Posting Start Date: 8/3/26 Posting End Date: 8/18/26 About the Role We are looking for a Senior Regulatory Affairs Product Associate to join our team within the Peripheral Business Group. In this role, you will develop and execute regulatory strategies to achieve and maintain global marketing approvals for new, modified, and existing implantable medical devices. You will lead the preparation, coordination, and execution of global regulatory submissions while partnering with cross-functional teams throughout the product development and product lifecycle. This is a remote position, and you can work from home in most locations within the United States. Responsibilities Partner with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals Coordinate and lead activities and timelines with applicable functional groups to complete regulatory submissions Evaluate product labeling, product claims, advertising, specifications, and changes for regulatory compliance and determine applicable regulatory requirements and submission needs Interact closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities, including recommendations regarding regulatory requirements and potential risks Integrate into the Regulatory Affairs team to facilitate collaborative and consistent regulatory counsel to product functional groups Represent Regulatory Affairs in quality system audits by external agencies Assist with post-market compliance requirements, including required regulatory reporting and lifecycle management activities Identify regulatory risks and recommend appropriate regulatory strategies, submission requirements, and paths forward for assigned products and projects Maintain compliance with training expectations as required for this position Required Qualifications Bachelor’s degree, and minimum 4 years of Regulatory Affairs experience in the medical device industry Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents Knowledge of FDA and international regulations related to Class II and Class III implantable medical devices Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, supplied components, packaging, or sterilization and determining associated regulatory requirements Successful experience leading or supporting submissions associated with device modifications and manufacturing process modifications Experience proactively identifying necessary submission content, assessing project documentation for completeness and regulatory compliance, including compliance with international standards Strong communication (oral, written, and interpersonal) skills, including the ability to effectively communicate regulatory requirements and collaborating effectively to cross-functional teams Demonstrated ability to analyze regulatory issues, assess regulatory risks, and recommend appropriate regulatory approaches Strong project management and organizational skills Ability to travel up to 15% Desired Qualifications Experience preparing or supporting submissions for PMA, IDE, or other Class III medical device products Experience preparing regulatory submissions for Class III medical devices under the European Medical Device Regulation (EU MDR) or another Tier 1 regulatory authority Experience with regulatory requirements for combination (drug/device) products This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies. * Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island. Information at a Glance Apply now About Gore For over 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. 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. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.