Regulatory Affairs Lead – NPD for Software/Devices

Cepheid; 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)

Job summary

Cepheid, a Danaher company in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory efforts on New Product Development, focusing on software and hardware with emphasis on cybersecurity. You will interact with US/EU authorities, drive submissions, and shape strategies for product launches.

The role requires a strong background in regulatory leadership, cross-functional collaboration, and extensive experience with FDA/IVDR/WHO PQ submissions, plus DBS process familiarity.

Qualifications

• Lead regulatory affairs on NPD core teams for medium to complex instrument or software projects.
• Develop regulatory strategy for software and hardware including cybersecurity deliverables.
• Prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) per project plan.

Responsibilities

• Lead RA on NPD core teams including medium to complex instrument/software projects.
• Develop regulatory strategy for software/hardware including cybersecurity and EMC.
• Prepare formal regulatory submissions (FDA, IVDR, WHO/PQ) as required.

Skills

RA leadership

Regulatory strategy

FDA submissions

Cybersecurity

Software regulation

Education

Bachelor’s degree in applicable field

Master’s degree in applicable field

Doctoral degree in applicable field

Job description

Cepheid, a Danaher company in Sunnyvale, CA, seeks a Regulatory Affairs Principal to lead regulatory efforts on New Product Development, focusing on software and hardware with emphasis on cybersecurity. You will interact with US/EU authorities, drive submissions, and shape strategies for product launches.

The role requires a strong background in regulatory leadership, cross-functional collaboration, and extensive experience with FDA/IVDR/WHO PQ submissions, plus DBS process familiarity.