Diagnostic Regulatory Affairs Manager - Remote

Overview

The Diagnostic Regulatory Affairs Manager at Amgen plays a crucial role in developing and implementing regulatory strategies for in vitro diagnostics and companion diagnostics while ensuring compliance with health regulations.

In Short

• Support establishing sustainable regulatory processes.
• Develop clinical and commercial regulatory strategies.
• Provide regulatory guidance for project planning.
• Handle interactions with diagnostic partners.
• Prepare for meetings with regulatory agencies.
• Review key regulatory submissions.
• Assess impact of regulations on development activities.
• Manage regulatory document systems.
• Collaborate with internal teams for IVD/CDx development.
• Support due diligence activities for potential partnerships.

Requirements

• In-depth knowledge of regulatory document management systems.
• Doctorate or relevant experience in Regulatory Affairs.
• 6+ years in Regulatory Affairs preferred.
• Experience with medical devices or IVD/CDx regulations.
• Strong communication and collaboration skills.
• Ability to influence project planning and decision-making.
• Experience with regulatory submissions (PMA, 510(k), IDE).
• Familiarity with international regulatory practices.
• Ability to manage multiple projects simultaneously.
• Proficient in VeevaVault and SharePoint.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with company contributions.
• Flexible work models including remote arrangements.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Health and welfare plans for employees and dependents.
• Work/life balance initiatives.
• Company-wide shutdowns for rest and rejuvenation.