Strategic Regulatory Lead for Implantable Medical Devices

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

RSU

401K

ESPP Program

Paid Time Off

Holidays

Job summary

NeuroPace in Mountain View, CA is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy for a complex active implantable US Class III medical device system. Hybrid role 2-3 days per week in office, with responsibilities across product development, submissions, labeling, and lifecycle management.

You will mentor teams, manage PMA submissions, and coordinate with regulators, clinical, quality, and engineering to ensure timely approvals and compliance.

Qualifications

• Bachelor’s degree in a scientific or technical field.
• 6-8 years in regulatory affairs for medical devices.
• PMA experience required; FDA regulations extensive knowledge.
• Experience with cybersecurity, software, and AI/ML preferred.
• Strong project management and cross-functional collaboration.

Responsibilities

• Develop regulatory strategies for new and modified products.
• Lead regulatory submissions (PMA, IDE, 30-day notices, etc.).
• Mentor cross-functional teams on regulatory processes.
• Maintain relationships with regulatory agencies.
• Ensure labeling and promotional materials compliance.
• Translate input from clinical, quality, and engineering into strategy.

Skills

Regulatory strategy

Team leadership

PMA experience

FDA regulations

Medical device

Clinical study submissions

Education

Bachelor’s degree in science or engineering

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

NeuroPace in Mountain View, CA is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy for a complex active implantable US Class III medical device system. Hybrid role 2-3 days per week in office, with responsibilities across product development, submissions, labeling, and lifecycle management.

You will mentor teams, manage PMA submissions, and coordinate with regulators, clinical, quality, and engineering to ensure timely approvals and compliance.