Director, Regulatory Affairs - In-Vitro Diagnostics (IVD)

Role Summary

Director of Regulatory Affairs for In-Vitro Diagnostics (IVD) and companion diagnostics (CDx) at Amgen. Leads and manages the regulatory affairs team to develop and implement regulatory strategies and processes for IVD/CDx, ensuring compliance across multiple regions. Based in Thousand Oaks, CA.

Responsibilities

• Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting inclusion, diversity, and collaboration.
• Oversee resource allocation and operational strategies to support complex development pipelines.
• Develop regulatory positions, best practices, and SOPs to support submissions and approvals.
• Lead cross-functional and global teams on regulatory issues, ensuring effective communication across stakeholders.
• Navigate IVD/CDx regulatory pathways, including co-development with drugs, clinical performance studies, analytical validations, and post-market compliance.
• Direct regulatory planning and submissions (e.g., PMA, 510(k), IDE) to achieve approvals across US, EU, Japan, and China.
• Collaborate with diagnostic partners on co-development programs to ensure alignment and compliance.
• Utilize regulatory tools and frameworks for content planning and reporting.
• Ensure adherence to regulations, guidance, and international standards (ISO 13485, ISO 14971, CLSI).
• Design and implement global regulatory strategies aligned with business goals and timelines.
• Anticipate regulatory challenges and solve issues proactively.
• Evaluate regulatory impact of new guidance, standards, and legislation on projects.
• Prepare and review regulatory documentation, submissions, and presentations with strong written and verbal communication.
• Manage relationships with regulatory agencies, diagnostic partners, and internal stakeholders; negotiate and influence as needed.
• Clearly articulate regulatory requirements and strategies to non-regulatory audiences.
• Represent the organization in external groups, forums, or standards organizations (e.g., PhRMA, BIO, AAMI, ISO).
• Demonstrate adaptability under pressure and maintain focus on results.
• Prioritize and manage multiple projects and deadlines with strong organizational skills.

Qualifications

• Basic Qualifications: Doctorate degree and 4 years of directly related experience; OR Master’s degree and 7 years of directly related experience; OR Bachelor’s degree and 9 years of directly related experience.
• Preferred Qualifications: Substantial experience leading CMC/Device Regulatory Affairs strategy and execution across product lifecycles; experience leading or participating in regulator meetings in US, EU, Japan, and China; knowledge of global CMC/Device regulations and evolving health authority expectations; proven coaching and mentorship ability.