Regulatory Affairs Professional- Remote Work Opportunity

About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.

About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries

About the Role: We are seeking an experienced Regulatory Affairs Professional to join our Medical Products Division team and are open to qualified candidates working remote from home; anywhere in the United States. In this role it will be required to plan, develop, and prepare regulatory strategies that includes writing and coordinating regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new, modified, and existing implantable medical devices.

• Working closely with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals
• Coordinating activities and timelines with applicable functional groups to complete regulatory submissions
• Evaluating product labeling, product claims, advertising, specifications, and changes for regulatory compliance
• Interacting closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities
• Integrating into the Regulatory Affairs team to facilitate collaborative and consistent regulatory counsel to product functional groups
• Representing Regulatory Affairs in quality system audits by external agencies
• Assisting with post-market compliance requirements
• Collaborating with and counsel the clinical team to ensure notifications and other reports are submitted as required during the course of clinical trials

Required Qualifications:

• Bachelor’s degree
• At least 3 years of Regulatory Affairs experience in the medical device industry
• Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents
• Experience proactively identifying necessary submission content and assessing the project documentation, including compliance with international standards
• 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
• Successful experience with submissions associated with device modifications and manufacturing process modifications
• Good communication (oral, written, and interpersonal skills)
• Attention to detail
• Good organizational skills
• Ability to interact effectively with many diverse functional groups
• Willingness to travel 15%

At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, Health & Well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more gore.com/careers.

We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity, and respect.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

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.

Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)

gore.com/change-life
Our Talent Acquisition Team will be pleased to answer your questions via gore.com/contact.