Director, Regulatory Affairs - In-Vitro Diagnostics (IVD) Job at Amgen (Thousand Oaks)

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

Amgen

Location:
United States , Thousand Oaks

Category:
-

Contract Type:
Not provided

Salary:

210840.00 - 251128.00 USD / Year

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Job Description:

Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks, CA location. 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).

Job Responsibility:

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, 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

Requirements:

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 in differing stages of the product lifecycle
Experience of 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

Nice to have:

Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for products in differing stages of the product lifecycle
Experience of 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

What we offer:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a 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

Additional Information:

Job Posted:
January 11, 2026

Employment Type:

Fulltime

Work Type:

On-site work

Amgen - All Job Offers

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

Amgen

Location:
United States , Thousand Oaks

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 11, 2026

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