Senior Manager, Regulatory Affairs
$138,700–$215,100 year
On-siteDenver, Colorado, United States
Job Summary
Lead global regulatory strategy and execution for CONMED medical devices, directing submission plans, agency engagement, and inspection readiness across domestic and international markets. Direct preparation and negotiation of regulatory applications with FDA, Notified Bodies, and Health Canada while managing post-approval obligations and labeling claims. Serve as a senior advisor to business and technical leaders, translating complex requirements into practical strategies that support product development and lifecycle management. Lead and develop the regulatory affairs team, coaching professionals to build technical capability and succession depth. Drive cross-functional alignment with R&D, Clinical, Quality, and Marketing to resolve regulatory issues and ensure deliverables are incorporated into project plans. Maintain a forward-looking understanding of medical device regulations, standards, and enforcement trends to assess business impact and lead implementation of regulatory expectations.
Required Qualifications
- Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline
- Minimum 8 years of directly relevant Regulatory Affairs experience in the medical device industry
- Hands-on authorship, review, or leadership of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related applications
- Minimum 5 years of experience leading regulatory strategy for new product development, design changes, sustaining engineering, or product lifecycle management in a regulated medical device environment
- Minimum 4 years of direct people-management experience, including hiring, performance management, talent development, coaching, and resource planning
- This is an on-site role, not hybrid or remote
Desired Qualifications
- Master's degree or MBA
- Regulatory Affairs Certification (RAC)
- Experience managing regulatory professionals and/or managers across multiple portfolios, locations, or business units
- Experience interacting directly with FDA, Notified Bodies, Health Canada, and other global regulatory authorities
- Strong working knowledge of FDA medical device regulations, EU MDR, Health Canada, and other international regulatory frameworks
- Demonstrated ability to lead regulatory strategy, manage competing priorities, identify approval risks, and develop practical mitigation plans
- Strong written and verbal communication skills with 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
- Experience supporting audits, inspections, technical documentation, labeling review, design controls, risk management, and product lifecycle management
- Proficiency with Microsoft Office, ERP systems, and regulatory information/document management systems
- Demonstrated ability to lead continuous improvement of regulatory processes, metrics, and inspection readiness
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