Manager, Regulatory Affairs

Overview 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 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 audits, inspections, technical documentation, labeling review, design controls, risk management, and product lifecycle management. Proficiency with Microsoft Office, multiple ERPs and regulatory information/document management systems. Education Requirements Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline required. Master's degree, MBA, or Regulatory Affairs Certification preferred. Physical Requirements Ability to sit and/or stand for extended periods during a standard workday and use a computer and standard office equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role. Benefits CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage Short & long term disability plus life insurance -- cost paid fully by CONMED Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period Employee Stock Purchase Plan -- allows stock purchases at discounted price Tuition assistance for undergraduate and graduate level courses Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives! CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment. Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at View phone number on click.appcast.io option #5. #J-18808-Ljbffr