Labeling and Post-Market Surveillance Regulatory Affairs Associate - Remote

We are looking for a Labeling and Post-Market Surveillance Regulatory Affairs associate to join our Regulatory Excellence team. In this role, you will provide strategic regulatory support across the product lifecycle, with a focus on labeling and post-market compliance for Class II and Class III implantable medical devices. You will collaborate cross-functionally to ensure global regulatory requirements are effectively integrated into product content and surveillance systems. Your contributions will shape regulatory best practices, support global submissions, and drive continuous improvement in regulatory processes and systems.

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

• Identify and continuously monitor the global regulatory and customer requirements for labeling of implantable medical devices
• Identify and continuously monitor the global regulatory requirements for post-market surveillance of implantable medical devices
• Collaborate with cross-functional teams to strategize and implement relevant global labeling and post-market surveillance regulatory requirements into content in accordance with the quality system
• Provide Regulatory Affairs quality system support of cross-product line activities for labeling and post-market surveillance (e.g. change orders, quality plans, protocols and reports)
• Provide expertise in global regulatory strategy development for labeling and post-market surveillance
• Prepare, write, coordinate, and interactively follow up on global submissions related to labeling for implantable medical devices
• Coordinate with applicable stakeholders to develop responses to requests from regulatory authorities regarding labeling and post-market surveillance
• Provide regulatory direction and active support for the development and/or use of standardized best practices, processes and tools
• Identify regulatory opportunities for training, system enhancements, and process harmonization
• Assist in internal and external quality system audits and develop strategic responses and corrective actions to audit findings

• Bachelor's degree
• Minimum of 3 years of experience working in a medical-device and/or pharmaceutical industry role directly involved in the application of regulations and standards
• Working knowledge of global directives and regulations with regards to labeling and post-market surveillance for Class II and III implantable medical devices
• Strong communication skills (oral, written, and interpersonal skills) adaptable to circumstance and audience
• Demonstrated ability to organize and complete complex projects on time and in compliance with requirements
• Demonstrated ability to influence in a complex, cross-functional organization
• Ability to prioritize work and adapt to shifting priorities
• Ability to work independently with limited supervision

• Bachelor's degree in engineering, biological, chemical, medical, or allied health sciences field
• Demonstrated experience in adopting global regulatory requirements into quality system standards, specifications, or procedures
• Experience with electronic labeling and company website requirements

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.