Regulatory Affairs Principal (Medical Diagnostics)

Location: Sunnyvale, California, United States; onsite role

Annual salary: $145,000–$199,500, plus eligible 15% bonus/incentive pay.

Company

Cepheid is a hirify.global operating company developing molecular diagnostic systems and tests for healthcare and life sciences.

What you will do

• Lead regulatory affairs activities on new product development core teams for instrument, software, and system projects.
• Prepare regulatory submissions and coordinate cross-functional work to support on-time product launches.
• Interact with regulatory agencies and health authorities to resolve queries and obtain product approvals.
• Develop regulatory strategies for US, EU, and WHO/PQ submissions, including software, cybersecurity, and EMC deliverables.
• Interpret new and changing regulations and guidelines, with a focus on software and cybersecurity.
• Implement continuous improvements and efficiencies using hirify.global Business System tools.

Requirements

• Bachelor’s degree in an applicable field and 8+ years of related experience, or a master’s degree and 6+ years, or a doctoral degree and 3+ years.
• Experience leading regulatory activities for medium to complicated instrument or software projects and submissions, including 510(k), De Novo, and Class A–D submissions.
• Experience developing regulatory strategies for software and hardware submissions covering software development, cybersecurity, and EMC requirements.
• Experience authoring, preparing, and supporting US FDA, EU IVDR, and WHO/PQ regulatory submissions.
• Ability to prepare formal written reports and presentations communicating regulatory strategies and status.
• Ability to work onsite in Sunnyvale, California, and travel approximately 15% as needed.

Nice to have

• Experience participating in project core teams, developing regulatory plans, and meeting project timelines.
• Experience with FDA pre-submissions, 510(k), PMA submissions, and EU technical documentation for software and hardware products.
• Experience critically reviewing software and hardware protocols, reports, and deliverables to identify gaps and define mitigations.

Culture & Benefits

• Work within a life sciences and molecular diagnostics environment focused on measurable healthcare impact.
• Benefits include paid time off and medical, dental, and vision insurance.
• Eligible employees receive access to a 401(k) program.
• Eligibility for annual bonus or incentive pay targeted at 15% of annual base salary.
• Career growth and development supported through a culture of belonging and continuous improvement.