On-Site Global Regulatory Lead, Medical Devices

CONMED Corporation; Denver (CO); On-site; USD 139,000 - 215,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

Short & long term disability plus life

Retirement Savings Plan (401K) with 7%

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation in Colorado is seeking a Senior Manager Regulatory Affairs to lead global regulatory strategy for medical devices, directing submissions, agency engagements, labeling review, and lifecycle support across markets.

You will partner with R&D, Quality, Marketing, and Operations to mitigate regulatory risks, manage resources, and drive continuous improvement while ensuring compliance with FDA, EU MDR, Health Canada, and other authorities.

Qualifications

• Bachelor's degree in science, biomedical engineering, engineering, regulatory affairs, or related discipline.
• 8+ years regulatory affairs experience in medical devices including submissions (510(k), technical files).
• 5+ years leading regulatory strategy for new product development and lifecycle management.
• 4+ years of direct people-management experience.

Responsibilities

• Lead global regulatory strategy for product portfolios, including submissions and market-entry decisions.
• Direct preparation, review, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and others.
• Advise senior leadership translating regulatory requirements into practical development timelines.
• Maintain knowledge of regulatory trends and implement expectations across teams.
• Coach and develop regulatory affairs professionals and manage resources.
• Drive cross-functional alignment with Marketing, R&D, Clinical, Quality, and Operations.
• Oversee labeling and promotional materials review for regulatory compliance.
• Lead process improvements, inspection readiness, audits, metrics.
• Report to senior management on strategy, risks, and impact.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Cross-functional collaboration

FDA interactions

Education

Bachelor's degree in science/engineering/regulatory affairs

Tools

Regulatory information systems

Job description

CONMED Corporation in Colorado is seeking a Senior Manager Regulatory Affairs to lead global regulatory strategy for medical devices, directing submissions, agency engagements, labeling review, and lifecycle support across markets.

You will partner with R&D, Quality, Marketing, and Operations to mitigate regulatory risks, manage resources, and drive continuous improvement while ensuring compliance with FDA, EU MDR, Health Canada, and other authorities.