Senior Manager, Risk Management & Post Market Surveillance (TPLC)

NeuroPace•Mountain View, CA

6d•$160,000 - $210,000

About The Position

Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive. We are currently seeking a Sr. Manager, Risk & Post-Market Surveillance (TPLC) to join our team. About the role We are seeking an experienced leader to drive post-commercialization risk management and data-driven safety analytics as part of our quality system. This role serves as a key resource in evaluating and improving risk management programs to ensure alignment with applicable regulations and standards and to inform total product life cycle efforts. Responsibilities include assessment & analysis, planning, documentation, and recommendation of remediation & improvement activities across product design and quality systems.

Requirements

Bachelor’s degree in engineering (software engineering preferred) with experience in statistics
Master’s degree in related field (Engineering, Statistics, or Analytics) or equivalent job experience
Minimum of 5+ years of experience in medical device risk management.
Strong working knowledge of FDA, EU MDR and IMDRF PMS regulations, including international standards such as ISO 14971, ISO 13485, 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 response(s) to findings.
Strong technical writing, communication, and project management skills.
Ability to work independently and as part of a cross-functional team.

Responsibilities

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