Overview In this role you will lead global regulatory strategy and execution for CONMED's medical devices, guiding submissions, labeling review, and lifecycle management across markets. You will partner with R&D, Quality, and Commercial teams to anticipate regulatory risks and shape product decisions. Youll drive inspection readiness and continuous process improvement while developing a high-performing regulatory affairs team. This on-site position offers a chance to impact global product success through strategic, cross-functional leadership.
Compensation / Benefits- Competitive compensation
- Excellent healthcare coverage
- Disability and life insurance fully paid by CONMED
- 401K with company match up to 7%
- Employee Stock Purchase Plan
- Tuition assistance
Responsibilities- Lead global regulatory strategy and path decisions for product portfolios, including approvals, risk assessment, and market-entry considerations
- Direct preparation, submission, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and other authorities; manage post-approval obligations
- Serve as senior advisor translating complex requirements into practical strategies aligned with timelines and business priorities
- Maintain awareness of evolving medical device regulations and guide cross-functional implementation
- Coach and develop regulatory affairs professionals, aligning resources to portfolio priorities
- Drive cross-functional alignment to resolve regulatory issues and integrate regulatory deliverables into project plans
- Oversee labeling, promotional, and product communications review to ensure regulatory compliance
- Enhance regulatory procedures, inspection readiness, audits, metrics, and continuous improvement
- Communicate regulatory strategy, portfolio status, risks, and impact to senior management
- Flexibly assume additional duties based on business needs
Key requirements- Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or related discipline
- 8+ years of regulatory affairs experience in medical devices with direct submission experience (e.g., 510(k), Technical Documentation/Files, international registrations)
- 5+ years leading regulatory strategy for product development, design changes, or lifecycle management in regulated devices
- 4+ years of people-management experience (hiring, performance, development, coaching)
- strong leadership and team development
- excellent communication for technical and executive audiences
- strategic thinking and risk-based decision making
- FDA regulatory submissions (510(k
- Technical Documentation/Technical Files
- EU MDR and Health Canada regulatory knowledge
