Regulatory Affairs Lead – NPD for Diagnostics

Radiometer; Sunnyvale (CA); On-site; USD 145,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) to eligible employees

Job summary

Cepheid, located in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory strategy for new product development. You will prepare submissions (US FDA, IVDR, WHO/PQ) and coordinate with cross‑functional teams to secure timely approvals for software and hardware solutions.

The role emphasizes cybersecurity, DBS tool experience, and providing clear regulatory plans for US and EU markets, with opportunities for growth within Danaher’s global ecosystem.

Qualifications

• Bachelor's degree or higher with 8+ years in regulatory affairs
• Master's degree with 6+ years in regulatory affairs
• Doctoral degree with 3+ years in regulatory affairs

Responsibilities

• Prepare regulatory submissions (US FDA, IVDR, WHO/PQ) for NPD projects.
• Lead regulatory strategy for software/hardware with cybersecurity considerations.
• Engage with health authorities to obtain product approvals and maintain compliance.
• Provide regulatory updates and communicate status to core teams.

Skills

Regulatory strategy

US FDA knowledge

EU IVDR knowledge

Cybersecurity awareness

Project collaboration

Education

Bachelor's degree in applicable field

Master's degree in applicable field

Doctoral degree in applicable field

Tools

PowerPoint

DBS tools

Job description

Cepheid, located in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory strategy for new product development. You will prepare submissions (US FDA, IVDR, WHO/PQ) and coordinate with cross‑functional teams to secure timely approvals for software and hardware solutions.

The role emphasizes cybersecurity, DBS tool experience, and providing clear regulatory plans for US and EU markets, with opportunities for growth within Danaher’s global ecosystem.