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

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.

What youll do

• 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.

What you will bring

• Bachelors degree in engineering (software engineering preferred) with experience in statistics
• Masters 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.

Why Join Us

• Be a key safety and compliance driver in a company committed to improving patient outcomes.
• Own a high visibility position with impact across the organization.
• Work in a collaborative forward-thinking environment where data-driven insights shape product strategy and patient care.

$160K-$210K Base - Compensation will be determined based on several factors including but not limited to skill set years of experience and geographic location.

NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable)