Manager, Regulatory Affairs

## The **Manager, Regulatory Affairs** leads regulatory strategy and execution for new and existing CONMED medical devices across domestic and international markets. This role manages regulatory submissions, agency interactions, labeling review, product lifecycle support, and cross-functional regulatory guidance while developing a team of regulatory professionals and ensuring alignment with business objectives, quality system requirements, and applicable global regulations. ## **\*\*\*This position is an on-site role located in Denver, CO\*\*\*** # **Responsibilities**: - ## Lead the development and execution of regulatory strategies for new, modified, and marketed medical devices, ensuring alignment with business priorities, product development timelines, and applicable U.S. and international regulatory requirements. - ## Direct the preparation, review, submission, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and other global regulatory authorities, including pre-submission planning, response strategy, and post-submission follow-up to support timely approvals. - ## Maintain current knowledge of medical device regulations, standards, guidance documents, and submission requirements; establish and maintain effective relationships with regulatory agencies, internal leaders, and cross-functional stakeholders. - ## Provide clear and timely communication to senior management regarding regulatory strategy, submission status, approval risks, emerging regulatory issues, and potential business impact. - ## Manage, coach, and develop regulatory affairs personnel by setting clear expectations, providing technical guidance, supporting professional development, and promoting effective collaboration with Marketing, R&D, Quality, Clinical, Operations, and other cross-functional partners. - ## Review and provide regulatory guidance for labeling, promotional, educational, and product communication materials to ensure compliance with approved indications, claims, and applicable regulatory requirements. - ## Support departmental procedures, regulatory processes, audit preparation, inspection readiness, and continuous improvement initiatives to strengthen regulatory execution and compliance. - ## Serve as the regulatory lead on product development, lifecycle management, design change, and sustaining engineering teams; assess regulatory impact and ensure required documentation and approvals are completed. # # **Minimum Requirements**: - ## Minimum 8 years of directly relevant Regulatory Affairs experience within the medical device industry. Experience must include hands-on preparation, authorship, review, or management of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related regulatory applications. - ## Prior experience supervising, mentoring, or leading regulatory professionals is required. **A minimum of 2 years of direct people-management experience, including hiring, performance management, talent development, coaching, and resource planning, is required, with additional years of experience preferred.** # **Preferred Requirements:** - ## Demonstrated ability to lead regulatory strategy, manage multiple priorities, and translate complex regulatory requirements into clear, practical plans for cross-functional teams. - ## Demonstrated ability to meet business timelines, prioritize effectively, and identify regulatory risks and mitigation plans. - ## Strong written and verbal communication skills, including the ability to communicate regulatory positions, submission strategy, and business impact to technical and executive audiences. - ## Demonstrated sound judgment, decision-making capability, and ability to work independently in a fast-paced, regulated environment. - ## Strong working knowledge of FDA medical device regulations, EU MDR, Health Canada, and other international regulatory frameworks. - ## Experience supporting…