Architect – Product Safety & Regulatory Engineering

I10065 GE BE Private Ltd; Bengaluru; On-site; INR 3,000,000 - 5,500,000; Full time

Benefits offered by this job

Relocation assistance provided

Job summary

GE HealthCare in Bengaluru seeks a senior leader to own Product Safety, Regulatory Compliance, Risk Management, and Design Controls for its X-Ray Tube and X-Ray Generator portfolio across the product lifecycle.

You will steer global cross‑functional teams to drive compliant product development, regulatory approvals, and risk‑based decision making that enables safe, reliable medical imaging solutions throughout lifecycle engineering initiatives.

Qualifications

• Bachelor's or Master's degree in Electrical, Electronics, Mechanical engineering, or a related field.
• Minimum 10 years of experience in Product Safety, Regulatory Engineering, Design Controls, Quality Engineering, or medical device compliance.
• Knowledge of medical device regulations and standards including IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO.
• Experience with Design Controls, risk management, verification/validation, lifecycle management, and regulatory compliance.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Provide technical leadership for Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tubes and Generators across development and lifecycle activities.
• Evaluate impact of engineering, supplier, component, and manufacturing changes to ensure ongoing compliance with global regulatory and product safety requirements.
• Lead product risk management activities including Hazard Analysis, Risk Assessments, DFMEA/PFMEA, and Product Safety Reviews.
• Lead regulatory compliance and product certification activities including IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO, RoHS/REACH as applicable.
• Drive PSRB activities, CCN, and regulatory assessments to address evolving global regulatory requirements.
• Review and approve technical documentation including Technical Files, DHF, DMR, Risk Management Files, and labeling.
• Provide regulatory and product safety oversight throughout the Design Control process (inputs, outputs, V&V, transfers, ECRs/ECOs).
• Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Service, and Sourcing to implement compliant product improvements.
• Support audits by providing technical expertise related to product safety, EMI/EMC compliance, and quality management systems.
• Drive continuous improvement initiatives strengthening regulatory compliance and lifecycle engineering across the portfolio.

Skills

Product Safety

Regulatory Engineering

Design Controls

Quality Engineering

Medical Device Compliance

EMI/EMC knowledge

Cross-functional collaboration

Education

Bachelor's or Master's in Electrical/Electronics/Mechanical engineering or related field

Job description

Job Description

Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for GE HealthCare's X-Ray Tube and X-Ray Generator portfolio across the entire product lifecycle. This role provides technical leadership to ensure new and installed-base products meet global safety, regulatory, and quality requirements while supporting product enhancements, design changes, supplier transitions, and lifecycle engineering initiatives. The Architect partners with cross-functional global teams to drive compliant product development, regulatory approvals, and risk-based decision making that enables safe, reliable, and innovative medical imaging solutions.

Key Responsibilities

• Provide technical leadership for Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tubes and X-Ray Generators across new product development and lifecycle engineering activities.
• Evaluate the impact of engineering, supplier, component, and manufacturing changes to ensure continued compliance with global regulatory and product safety requirements.
• Lead product risk management activities, including Hazard Analysis, Risk Assessments, Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Product Safety Reviews.
• Lead regulatory compliance and product certification activities, including support for IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO, UL, CSA, ETL, RoHS, REACH, and other applicable regional requirements.
• Drive Product Standards Review Board (PSRB) activities, Country Compliance Notifications (CCN), and regulatory assessments to address evolving global regulatory requirements.
• Review and approve technical documentation including Technical Files, Design History Files (DHF), Device Master Records (DMR), Risk Management Files, product specifications, labeling, user documentation, and compliance records.
• Provide regulatory and product safety oversight throughout the Design Control process, including Design Inputs, Design Outputs, Verification, Validation, Design Transfer, Engineering Change Requests (ECRs), and Engineering Change Orders (ECOs).
• Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Service, Supplier Quality, and Sourcing teams to implement compliant product improvements and resolve technical compliance issues.
• Support internal, external, regulatory, certification, and customer audits by providing technical expertise related to product safety, EMI/EMC compliance, regulatory requirements, and quality management systems.
• Drive continuous improvement initiatives that strengthen regulatory compliance, product safety, and lifecycle engineering processes across the X-Ray Generation product portfolio.

Basic Qualifications

• Bachelor's or Master's degree in Electrical Engineering, Electronics Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 10 years of experience in Product Safety, Regulatory Engineering, Design Controls, Quality Engineering, Medical Device Compliance, or a related technical discipline.
• Demonstrated knowledge of medical device regulations and standards, including IEC 60601, ISO 14971, ISO 13485, FDA regulations, EU MDR, NMPA, CDSCO, and other applicable global regulatory requirements.
• Experience with Design Controls, design change management, risk management, verification and validation, product lifecycle management, and regulatory compliance.
• Working knowledge of EMI/EMC requirements and product certification processes.
• Experience supporting complex medical devices, preferably X-Ray Tubes, X-Ray Generators, medical imaging systems, or related electromechanical products.

Desired Characteristics

• Strong technical leadership with a systems engineering mindset.
• Demonstrated ability to influence and collaborate across global cross-functional teams.
• Excellent analytical, problem-solving, and risk-based decision-making skills.
• Strong written and verbal communication skills with the ability to communicate complex technical concepts to diverse stakeholders.
• Experience balancing innovation, quality, regulatory compliance, and business objectives.
• Self-motivated with a continuous improvement mindset and strong execution focus.

Relocation Assistance

Relocation Assistance Provided: Yes

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.