Director, Regulatory Affairs - In-Vitro Diagnostics; IVD

Director, Regulatory Affairs – In‑Vitro Diagnostics (IVD)

Amgen – Thousand Oaks, CA

• 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 team’s 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 admits, 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.

• Doctorate degree and 4 years of directly related experience.
• Master’s degree and 7 years of directly related experience.
• Bachelor’s degree and 9 years of directly related experience.

• Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for products at different stages of the product lifecycle.
• Experience leading and/or participating in meetings with regulators in major markets (US, EU, Japan, and China).
• Knowledge of global CMC/Device regulations and understanding of evolving challenges and health authority expectations.
• Track record as a strong coach and mentor.

• The expected annual salary range for this role in the United States (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
• Total Rewards Plan comprising health and welfare plans, financial plans, work/life balance initiatives, and career development opportunities.
• Comprehensive employee benefits package:
  Retirement and Savings Plan with generous company contributions, group medical, dental and vision suure coverage, life and disability insurance, flexible spending accounts.
• Discretionary annual bonus program; for field sales representatives называемый sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models, including remote and hybrid work arrangements where possible.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.