GE HealthCare Product Safety Regulatory Engineer 

India, Karnataka 

285477147

Learn practical application of engineering principles, understand design changes and achieve expertise in product life cycle change management. For this position, it would be ideal to have prior experience in product safety and regulatory, life cycle management of subsystems and system parts in medical devices.
Roles and Responsibilities:

• Ensure X-ray generator and tube subsystems comply with current product safety and regulatory standards across CT, RAD, Surgery, and Interventional systems in close interaction with system engineering team .

• Stay informed about evolving regulations and standards in the medical imaging field, particularly those related to X-ray technology, provide expert guidance on safety and regulatory matters to design team for product compliance.

• Collaborate with product engineering and regulatory affair teams at GE HealthCare to meet the region specific safety and regulatory requirements for X-Ray generators and Tubes.

• Conduct and lead periodic product standard board reviews, Country-specific compliance Notifications (CCNs), and Failure Mode and Effects Analyses (FMEAs).

• Perform risk assessments for X-ray generator and tube subsystems, identifying potential hazards and implementing risk mitigation strategies.

• Maintain and update a comprehensive product standards inventory for X-ray generators and tubes.

• Assess the impact of changes in industry standards on existing products and new developments.

• Drive regulatory compliance and certificate-related activities (IEC, RoHS, REACH, MDR, CE mark, UL, CSA, and NMPA certificates).

• Support product-level initiatives addressing regulatory compliance.

• Develop and maintain documentation supporting product safety and regulatory compliance. Maintain and update product technical documentation, including Technical Reference Manuals (TRM), essential requirement check list, Product Data Sheets (PDS) and Product labels.

• Contribute to the creation and revision of internal procedures related to product safety and regulatory compliance.

• Provide expert guidance on safety and regulatory matters to engineering, quality, and regulatory affairs teams.

• Collaborate closely with Engineering, New Product Introduction (NPI), Quality & Regulatory, Manufacturing, Suppliers, Sourcing, and Materials teams to implement engineering changes in products from design inputs to respective design outputs as required by regulations throughout the product lifecycle.

• Engage as an engineering representative in audits such as GMED, UL, CSA, and FDA for product safety and regulatory as part of site-level Quality Management System (QMS) requirements.

• Participate in audits , Liaise with certification bodies as needed to clarify requirements or resolve compliance issues.

• Stay informed about evolving regulations and standards in the medical imaging field, particularly those related to X-ray generation technology.

• Conduct periodic reviews of country-specific regulatory change notifications and global product standards.

• Conduct product risk management reviews, participate in Design FMEA (DFMEA), Process FMEA (PFMEA) and problem-solving processes.

Basic Qualifications:

• Master’s/ Bachelor's degree in Electrical/Electronics, Mechanical, Biomedical or related Engineering field

• 6+ years of experience in medical device safety and regulatory compliance

• Specific experience with X-ray generators and tubes for CT, RAD, and Vascular systems

• In-depth knowledge of medical device regulations (FDA, EU MDR, NMPA, ISO 13485)

• Proficiency in IEC 60601 series standards and relevant medical imaging standards particularly for X-Ray Tubes and Generators

• Experience with product testing, certification, interaction with certification bodies and audits

Desired Characteristics:

• Self-starter, energizing, results-oriented, and able to multi-task

• Seeks mentoring to learn and for problem-solving

• Excellent teamwork, coordination, and collaboration skills with cross-functional teams

• Global product lifecycle management experience

• Ability to meet high say-to-do ratio with prompt response

• Six Sigma Green Belt certification preferred

• Proficiency in risk management techniques

• Expertise in radiation safety and protection is an added advantage.

• Excellent communication and technical writing skills

• Project management experience

Inclusion and Diversity

Ourare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.