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Companion / In Vitro Diagnostics Regulatory Affairs Manager (Open to remote)

Organization

Amgen

Job Location

Thousand Oaks, CA
Los Angeles, CA 91320
United States

Benefits

401k
Medical/Dental/Vision
Healthcare and Daycare Reimbursement option
Fitness Club reimbursement program
Wellness programs offering discount on medical plans
LTI - Restricted Stock award annually
Annual Bonus program

Job Description

Companion Diagnostics/IVD Regulatory Affairs Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
• Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
• Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities.
• Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners.
• Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE).
• In collaboration with diagnostic partners and internal teams, preparing for and implementing meetings with regulatory agencies.
• Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
• Interacting with international regulatory colleagues and diagnostic partners to determine standard processes & least burdensome regulatory paths towards development & global registration activities.
• Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively.
• Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed.

Requirements

Basic Qualifications:
Doctorate degree OR Master’s degree and 2 years of Health Agency or Med-Device or Regulatory experience OR Bachelor’s degree and 4 years of Health Agency or Med-Device or Regulatory experience OR Associate’s degree and 10 years of Health Agency or Med-Device or Regulatory experience OR
High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience
Preferred Qualifications:
• MS Degree
• Degree in Regulatory Affairs, Life Sciences, or Engineering
• 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations
• 8 plus years of experience in medical device and/or IVD/CDx industry

About Our Organization

At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.