Company:A Large Global Organization Key

Skills:
Medical Imaging Systems, Product Safety Engineering, Regulatory Compliance, Safety Regulations, Product Security, Risk Management, Hazard Analysis, Systems Engineering, Medical Device Development, Certification and Compliance Frameworks Roles &

Responsibilities:
• Define and implement product safety engineering methods for medical imaging equipment and related devices.
• Interpret applicable regional and national regulations, standards and certification requirements, and communicate their impact to engineering teams.
• Identify, evaluate and mitigate safety and product security risks throughout recent product development and product changes.
• Coordinate compliance reviews, third-party testing, certification activities and resolution of findings with engineering, quality and supply chain teams.
• Lead technical discussions and small-to-medium projects, providing guidance to engineers and driving decisions that meet product quality, performance and schedule objectives. Skills Required:




• Demonstrated experience in new product development for complex medical, healthcare or regulated products.
• Strong knowledge of regulatory compliance and safety regulations compliance, including interpretation and application of technical standards.
• Hands-on experience with product security considerations across the product lifecycle.
• Ability to translate safety, regulatory and security requirements into system-level design inputs, verification activities and certification evidence. Good to Have:
• Experience in formal risk assessment, hazard analysis or risk-based design for medical devices.

Education:
• Bachelor's degree in Engineering, Technology or a related technical discipline from an accredited university or college.
• 7
- 16 years of relevant experience in safety engineering, regulatory engineering, systems engineering, product compliance or medical device development.

📌 Safety & Regulatory Engineer_105482 (Bengaluru)
🏢 MyCareernet
📍 Bengaluru