About the Role

We are looking for an experienced Regulatory Affairs Product Associate to join our team with the Aortic Business Group. In this role, you will plan, develop, and prepare regulatory strategies and coordinate regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new, modified, and existing products, as well as, develop global regulatory strategies and prepare, write, coordinate, and interactively follow up on global submissions for implantable medical devices.

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

Responsibilities

• Work closely with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals
• Coordinate activities and timelines with applicable functional groups to complete regulatory submissions
• Evaluate product labeling, product claims, advertising, specifications, and changes for regulatory compliance
• Interact closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities
• 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
• Collaborate with and counsel the clinical team to ensure notifications and other reports are submitted as required during the course of clinical trials
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required within the scope of position

Required Qualifications

• Bachelor’s degree and at least 3 years of Regulatory Affairs experience in the medical device industry
• Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents
• 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
• 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
• Good communication (oral, written, and interpersonal skills), attention to detail and good organizational skills
• Ability to interact effectively with many diverse functional groups
• Ability to prioritize work and adapt to shifting priorities
• Ability to travel up to 15%

Desired Qualifications

• Experience with submissions for PMA products
• Experience filing Class III device design dossiers under the European Medical Device Regulations, or filing submissions in another Tier 1 country
• Experience filing required notifications and reports during clinical trials

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.