Director, Regulatory Affairs - In-Vitro Diagnostics; IVD

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

We’re looking for a Director of Regulatory Affairs to work in Thousand Oaks, CA. The Regulatory Affairs division establishes sustainable processes, assures informed relationships, and delivers strategic outcomes. In this vital role, you will lead and manage the team responsible for developing and implementing optimal regulatory strategies and processes for in‑vitro diagnostics (IVDs) and companion diagnostics (CDx). Key responsibilities will include:

• Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture of inclusion, diversity, and collaboration.
• Oversee resource allocation and operational strategies to effectively support the complex development pipelines.
• Develop regulatory positions, best practices, and SOPs to ensure efficient support for submissions and approvals.
• Lead cross‑functional and global teams on regulatory issues, ensuring seamless communication and collaboration across all stakeholders.
• Lead the team to navigate IVD/CDx regulatory pathways, including the drug/diagnostics co‑development process, clinical performance studies, analytical validations, and post‑market compliance.
• Direct the team to develop and execute regulatory planning and submissions (e.g., PMA, 510(k), IDE) to achieve approvals across multiple regions, including the US, EU, Japan, and China.
• Collaborate with diagnostic partners on co‑development programs, ensuring alignment and compliance.
• Utilize regulatory tools, such as databases and frameworks, for efficient content planning and reporting.
• Ensure the teams adherence to regulations, guidance and international standards, including ISO 13485, ISO 14971, and CLSI guidelines.
• Design and implement global regulatory strategies that align with business goals and product development timelines.
• Anticipate and address regulatory challenges proactively through strong problem‑solving skills.
• Evaluate the regulatory impact of new guidance, standards, and legislation on ongoing and future projects.
• Prepare and/or review comprehensive regulatory documentation, submissions, and presentations with exceptional written and verbal communication skills.
• Manage relationships with regulatory agencies, diagnostic partners, and internal stakeholders through strong negotiation and influencing skills.
• Clearly articulate complex regulatory requirements and strategies to non‑regulatory audiences, fostering alignment and understanding.
• Represent the organization in external working groups, forums, or standards organizations (e.g., PhRMA, BIO, AAMI, ISO).
• Demonstrate adaptability and resilience under pressure, maintaining a focus on achieving results.
• Effectively prioritize and manage multiple projects and deadlines through strong organizational skills.

The dynamic professional we seek is a leader with these qualifications.

• Doctorate degree and 4 years of directly related experience.
• Masters degree and 7 years of directly related experience.
• Bachelors degree and 9 years of directly related experience.

• Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for…