Senior Regulatory Affairs Manager – Medical Devices (Hybrid, CA)

NeuroPace; Mountain View (CA); Hybrid; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401K

RSU

ESPP Program

Health & Wellness Program

Generous PTO & holidays

FSA & Commuter Benefits

Job summary

NeuroPace, based in Mountain View, CA, seeks a Senior Regulatory Affairs Manager to lead regulatory support for new product development, sustaining, and clinical study projects for a fully implantable US Class III medical device system. This hybrid role requires involvement 2-3 days in the Mountain View office.

You will supervise regulatory staff, drive submissions (PMA/IDE), and ensure compliance across lifecycle, partnering with clinical affairs, biocompatibility, software, and cybersecurity

Qualifications

• Bachelor’s degree in a scientific or technical discipline required.
• 6-8 years regulatory affairs medical device industry experience; 3+ years people management preferred.
• Thorough understanding of FDA regulations; PMA experience required; international regulations a plus.
• Working knowledge of active implantable medical devices (hardware/software) is required.
• Experience with cybersecurity, AI, and ML regulatory aspects is preferred.
• Strong project management, written/oral communication, and cross-functional collaboration.

Responsibilities

• Develop regulatory strategies for new/modified products to enable timely approvals.
• Provide regulatory feedback throughout product development lifecycle.
• Coordinate regulatory submissions (PMA, IDE, 30-day notices, annual reports).
• Review labeling and promotional materials for compliance.
• Build relationships with regulatory reviewers across product lifecycle.
• Mentor teams and develop departmental policies and procedures.
• Align Quality/Regulatory perspectives across the Total Product Lifecycle.

Skills

Regulatory affairs

FDA regulations

PMA experience

Project management

Clinical trial strategy

Regulatory submissions

Communication

Cybersecurity/AI/ML awareness

Education

Bachelor’s degree in science/engineering

Advanced degree or professional certification preferred

Tools

MS Office

Adobe

Job description

NeuroPace, based in Mountain View, CA, seeks a Senior Regulatory Affairs Manager to lead regulatory support for new product development, sustaining, and clinical study projects for a fully implantable US Class III medical device system. This hybrid role requires involvement 2-3 days in the Mountain View office.

You will supervise regulatory staff, drive submissions (PMA/IDE), and ensure compliance across lifecycle, partnering with clinical affairs, biocompatibility, software, and cybersecurity