Senior Manager, Risk & Post Market Surveillance (TPLC)

NeuroPace•Mountain View, CA

13h•$160,000 - $185,000

About The Position

NeuroPace is seeking an experienced middle-management leader to drive post-commercialization risk management and data-driven safety analytics as part of its quality system. The role evaluates and improves risk management programs to support compliance with applicable regulations and standards and inform total product life cycle efforts. It includes assessment and analysis, planning, documentation, and recommendations for remediation and improvement across product design and quality systems.

Requirements

Bachelor’s degree in engineering, preferably software engineering, with experience in statistics.
Minimum of 5 years of experience in medical device risk management.
Strong working knowledge of FDA, EU MDR, and IMDRF post-market surveillance regulations and international standards, including ISO 14971, ISO 13485, and FDA 21 CFR Part 803/820.
Proficiency in statistical analysis and visualization tools such as MS Power BI, R, JMP, JAMA, Minitab, SAS, or Python.
Proven experience interpreting post-commercialization product use data and planning total quality systems responses to findings.
Strong technical writing, communication, and project management skills.
Ability to work independently and as part of a cross-functional team.

Nice To Haves

Master’s degree in a related field, such as Engineering, Statistics, or Analytics, or equivalent job experience.

Responsibilities

Serve as a subject matter expert in post-commercialization risk management processes and data-driven safety analytics.
Lead cross-functional efforts and meetings to analyze and synthesize complex data into actionable insights for senior leadership and other stakeholders, supporting total product lifecycle improvements through the product development pipeline.
Maintain ISO 14971-compliant risk files, develop global Post-Market Surveillance plans, and use advanced statistical tools to detect emerging performance signals.
Implement and instruct staff on risk management remediation directives based on findings and analysis, and support training where applicable, with a focus on post-market product field use.
Ensure ongoing maintenance, continuous improvement, and remediation efforts meet applicable quality and regulatory standards.
Drive organizational change so cross-functional stakeholders align and integrate recommended risk remediation activities based on data-driven analysis.