Bachelor's degree in engineering (software engineering preferred) with experience in statistics
Master's degree in related field or equivalent job experience
Minimum of 5+ years of experience in medical device risk management
Strong knowledge of FDA, EU MDR, and IMDRF PMS regulations
Proficiency in statistical analysis and visualization tools
Experience interpreting post-commercialization product use data
Strong technical writing, communication, and project management skills
Responsibilities
Serve as a subject matter expert in post-commercialization risk management processes
Lead cross-functional efforts to analyze complex data into actionable insights
Maintain ISO 14971-compliant risk files and develop global Post-Market Surveillance plans
Implement and support training on risk management remediation directives
Ensure ongoing maintenance and improvement efforts meet quality and regulatory standards
Drive organizational change to align stakeholders on risk remediation activities
Benefits
Medical, Dental & Vision Insurance
Voluntary Life
401K
RSU
529 plan
ESPP Program
Health & Wellness Program
Generous Paid Time Off plus eleven paid holidays
FSA & Commuter Benefits
Full Job Description
We are currently seeking a Sr. Manager, Risk & Post-Market Surveillance (TPLC) to join our team.
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.
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-$185K Base - Compensation will be determined based on several factors, including but not limited to skill set, years of experience, and geographic location.
