Senior Regulatory Affairs Professional

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.

• 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

• 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%

• 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