Purpose of this position / Position summary

Governance and harmonization of the global product risk management framework across ZEISS Vision. Ensure appropriate capabilities in the organization by training. Leading risk management for assigned products and projects throughout the product lifecycle

Primary duties and responsibilities:

Global Product Risk Management Process and Governance

- You govern and harmonize the global product risk management framework across ZEISS Vision.
- You define, harmonize, maintain, and improve the global risk management process, methods, and documentation requirements.
- You ensure proportionate application across product types, technologies, and lifecycle phases.
- You monitor regulatory and state-of-the-art developments and initiate required process updates.
- You oversee process implementation and drive corrective and improvement actions.
- You build organizational capability through training, coaching, and expert guidance.
- You maintain standardized digital risk management content and libraries.
- You represent product risk management in audits, management reviews, and global forums

Product Risk Management Responsibility

- You lead risk management for assigned products and projects throughout the product lifecycle.
- You prepare, maintain, and integrate the required risk management documentation.
- You guide teams through risk analysis, evaluation, control, and residual risk assessment.
- You ensure risk control measures are implemented,



verified, and traceable.
- You keep product risks current using lifecycle and post-market information.
- You collaborate with interdisciplinary project and lifecycle teams.
- You support audits with clear and traceable evidence of compliant implementation.

Job Requirement :

- Master’s degree in medical device technology, natural sciences, or another relevant field
- 5+ years’ profound experience in maintaining product risk management documentation throughout the product lifecycle
- Demonstrated experience in governing risk management processes across multiple products, business units, or locations
- Experience in building organizational capabilities through training
- Experience with digital QMS and requirements management is an advantage (e.g. Polarion, Veeva)

Knowledge / Skills / Other characteristics

- Strong knowledge of ISO 14971, TSO/TR 24971, IMDRF, ISO 13485, MDR, MDSAP, or FDA QMSR
- Knowledge of general product safety regulations, cybersecurity and qualification as auditor is a plus.
- Strong communication skills, the ability to work efficiently in a hybrid setting, and experience providing expert guidance to risk management teams
- Proficiency in MS Office applications
- A meticulous, independent, and structured approach to work
- Strategic thinking combined with a hands-on and pragmatic working style
- Business-level proficiency in spoken and written English

📌 Global Product Lifecycle Manager – Risk Management (Bengaluru)
🏢 Zeiss India
📍 Bengaluru