At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
The Systems Engineer Regulatory Compliance & Post-Market Surveillance is responsible for analyzing post-market complaint data to identify trends, assess patient safety and device performance risks, and ensure compliance with U.S. and global medical device regulations. This role plays a critical part in complaint trending, MDR determination, CAPA escalation, and management review, ensuring traceable, data-driven decisions that withstand FDA and audit scrutiny.
The role partners closely with Quality, Regulatory Affairs, Risk Management, Clinical, and Engineering teams and is especially suited to complex electromechanical or robotic medical device environments.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
Regulatory Compliance & Post-Market Surveillance
- Ensure complaint trending and analysis processes comply with 21 CFR Part 820 (Complaint Handling) and 21 CFR Part 803 (Medical Device Reporting MDR)
- Support identification and evaluation of potentially reportable events, ensuring timely escalation and regulatory compliance
- Maintain traceable documentation suitable for FDA inspections, internal audits, and notified body reviews
Data-Driven Complaint Trend Analysis
- Perform monthly aggregation and analysis of complaint data by:
- Device / subsystem
- Failure mode
- Severity and harm classification
- Complaint and event rates
- Apply defined statistical and/or qualitative trending methodologies (e.g., rate-based trends, control charts, threshold analysis)
- Identify emerging signals and confirm trend validity through data quality checks
Risk Management & Patient Safety Assessment
- Evaluate complaint trends for potential patient safety, clinical risk, and device performance impact
- Link identified trends to risk management activities per ISO 14971
- Support updates to risk files, hazard analyses, and risk controls based on post-market evidence
Escalation, CAPA & Actionability
- Clearly identify trends requiring escalation, including:
- CAPA initiation
- Design or process changes
- MDR reporting or regulatory notification
- Document clear, defensible rationale for escalation or non-escalation decisions
- Partner with Engineering, Quality, and Manufacturing teams to support corrective and preventive actions
Management Review & Audit Readiness
- Prepare concise, traceable trend reports for management review
- Ensure reports clearly document:
- Data analyzed
- Conclusions reached
- Decisions made
- Actions and next steps
- Support regulatory inspections, audits, and health authority inquiries related to complaint trending and post-market surveillance
What Makes You Stand Out
Preferred Qualifications
- 4 to 6 years total experience in regulated medical device environments
- Experience with robotic, software-driven, or capital medical equipment
- Experience participating in FDA inspections or regulatory audits
- Strong understanding of complaint-to-CAPA and complaint-to-risk linkages
- Six Sigma, CQE, or quality-related certifications (preferred)
Core Competencies
- Strong analytical and systems-thinking mindset
- Ability to translate data into defensible regulatory decisions
- Excellent documentation and audit-readiness discipline
- Clear communication with Quality, Regulatory, Engineering, and leadership teams
- High ownership for patient safety and compliance outcomes
Your Background
Relevant Technical Skills
- 4 to 6 years of experience in medical device systems engineering, quality engineering, or post-market surveillance
- 3+ years of hands-on experience with complaint handling, complaint trending, or post-market analysis
- Demonstrated experience supporting FDA-regulated medical devices
- Experience in complex electromechanical systems; robotic medical device experience strongly preferred
Technologies & Tools
Quality & Regulatory Systems
- Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
- Complaint handling and MDR tracking systems
- CAPA and risk management workflows
Data Analysis & Reporting
- Excel (advanced), statistical analysis tools
- Business intelligence or reporting tools (e.g., Power BI, Tableau preferred)
- Trend analysis methods (rate-based, severity-weighted, qualitative assessments)
Risk Management
- ISO 14971 risk management frameworks
- Hazard analysis, FMEA/FMECA, fault tree analysis (support level)
Regulatory & Standards
- 21 CFR Part 820 (Quality System Regulation)
- 21 CFR Part 803 (Medical Device Reporting)
- ISO 13485 (preferred)
- Post-market surveillance and vigilance requirements
Education And Experience Requirements
- Bachelor's degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical field (or equivalent experience)
EOE/M/F/Vet/Disability
