Senior Manager, Risk & Post Market Surveillance (TPLC)
NeuroPace
Summary
We are seeking an experienced middle management leader to drive post-commercialization risk management and data-driven safety analytics as part of our quality system. The 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. The role involves assessment & analysis, planning, documentation, and recommendation of remediation & improvement activities across product design and quality systems.
Job description
About the role
We are seeking an experienced middle management leader to drive post-commercialization risk management and data-driven safety analytics as part of our quality system. The 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. The role involves assessment & analysis, planning, documentation, and recommendation of remediation & improvement activities across product design and quality systems.
What you'll do
- 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 key stakeholders to drive total product lifecycle improvements through the product development pipeline.
- 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.
What you will bring
- 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.
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
- Knowledge of ISO 14971, ISO 13485, FDA 21 CFR Part 803/820
- Proficiency in statistical analysis and visualization tools (MS Power BI, R, JMP, JAMA, Minitab, SAS, or Python)
- Proven experience interpreting post-commercialization product use data and planning total quality systems responses
- Strong technical writing, communication, and project management skills
- Ability to work independently and as part of a cross-functional team
Benefits
- Medical, Dental & Vision Insurance
- Voluntary Life Insurance
- 401(k)
- RSU
- 529 Plan
- ESPP Program
- Health & Wellness Program
- Generous PTO
- Eleven Paid Holidays
- FSA & Commuter Benefits
Company overview
NeuroPace is a commercial-stage medical device company based in Mountain View, California, specializing in neuromodulation technology for neurological disorders. Founded in 1999, the company has developed the RNS® System, the world's first and only FDA-approved brain-responsive neurostimulation platform for treating drug-resistant focal epilepsy. This innovative closed-loop technology functions similarly to a cardiac pacemaker but for the brain, continuously monitoring brain activity and delivering personalized, real-time treatment at the seizure source. The RNS System represents a paradigm shift in epilepsy treatment, offering a data-driven approach that recognizes individual seizure patterns and responds with imperceptible stimulation to prevent seizures. NeuroPace's technology has demonstrated significant clinical benefits, including substantial reductions in seizure frequency and improvements in quality of life for patients who have not responded to traditional medications. The company operates in the medical equipment manufacturing sector and has established partnerships with comprehensive epilepsy centers across the United States. With its proprietary device data capabilities and expanding clinical indications, NeuroPace is positioned as a leader in responsive neuromodulation technology for neurological conditions.