Regulatory Affairs Lead, NPD — Software & Cybersecurity

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

Benefits offered by this job

Bonus / incentive pay

Medical, dental, vision insurance

Paid time off

Job summary

Cepheid, a Danaher company, is seeking a Regulatory Affairs Principal to lead US/EU submissions for medium to complex instrument and software projects in Sunnyvale, CA. This onsite role demands strong regulatory strategy, cross-functional collaboration, and experience with FDA/IVDR/PQ processes.

You will prepare submissions, interpret changing regulations, and drive DBS-driven process improvements while mentoring teams and ensuring on-time product launches with a focus on software and

Qualifications

• Bachelor's, Master's or Doctoral degree in a relevant field with years of experience.
• Leads regulatory submissions (US-FDA, IVDR, WHO PQ) for NPD projects.
• Develops regulatory strategy for software and hardware including cybersecurity.

Responsibilities

• Prepare regulatory submissions and interact with agencies for timely product launches.
• Interpret new US/EU regulations and advise cross-functional teams.
• Lead RA for NPD core teams on instrument or software projects.
• Communicate regulatory status through reports and presentations.

Skills

Regulatory submissions

NPD project leadership

FDA/IVDR submissions

Education

Bachelor's degree

Master's degree

Doctoral degree

Job description

Cepheid, a Danaher company, is seeking a Regulatory Affairs Principal to lead US/EU submissions for medium to complex instrument and software projects in Sunnyvale, CA. This onsite role demands strong regulatory strategy, cross-functional collaboration, and experience with FDA/IVDR/PQ processes.

You will prepare submissions, interpret changing regulations, and drive DBS-driven process improvements while mentoring teams and ensuring on-time product launches with a focus on software and