Regulatory Affairs Lead, NPD & Cybersecurity (MedTech)

MedDeviceJobs; Sunnyvale (CA); On-site; USD 146,000 - 197,000; Full time

Benefits offered by this job

Bonus / incentive pay

Benefits package

Job summary

Cepheid, a Danaher operating company, is seeking a Regulatory Affairs Principal to lead regulatory efforts on NPD programs in Sunnyvale, CA. This on-site role collaborates with cross-functional teams to secure US FDA and EU IVDR approvals, including software and cybersecurity deliverables.

The role demands deep regulatory experience, the ability to build strategies, and interaction with health authorities across multiple regions. Travel ~15% may be required as projects demand.

Qualifications

• Bachelor’s degree with 8+ years of related work experience OR Master’s with 6+ years OR Doctoral with 3+ years.
• Leads on new product (NPD) core teams including medium to complicated instrument or software projects and submissions (510(k), De Novo, Class A–D).
• Develop regulatory strategy for software and hardware submissions including cybersecurity and EMC deliverables.
• Authors and supports regulatory submissions (US-FDA, IVDR, WHO/PQ) per project plan.

Responsibilities

• Prepare regulatory submissions and interact cross-functionally to ensure on time delivery of product launches.
• Interact with regulatory agencies to obtain product approvals with focus on US and EU IVDR and WHO PQ submissions.
• Represent to gather regulatory changes and interpret guidelines for US and EU, focusing on software and cybersecurity.
• Communicate regulatory strategies and status via formal reports and presentations.

Skills

Regulatory strategy

US FDA submissions

IVDR

US/EU regulatory submissions

Software regulatory

Cybersecurity regulatory

Regulatory intelligence

Cross-functional leadership

Education

Bachelor’s degree in applicable field

Master’s degree in applicable field

Doctoral degree in applicable field

Job description

Cepheid, a Danaher operating company, is seeking a Regulatory Affairs Principal to lead regulatory efforts on NPD programs in Sunnyvale, CA. This on-site role collaborates with cross-functional teams to secure US FDA and EU IVDR approvals, including software and cybersecurity deliverables.

The role demands deep regulatory experience, the ability to build strategies, and interaction with health authorities across multiple regions. Travel ~15% may be required as projects demand.