Cochlear is seeking a Senior Regulatory Affairs Specialist in Kuala Lumpur, Malaysia, to provide regulatory support throughout the lifecycle of its medical devices. The role involves guiding teams on regulatory requirements, managing submissions, and collaborating with cross-functional teams to ensure compliance
Job Summary
The Senior Regulatory Affairs Specialist provides regulatory support across the full lifecycle of Cochlear products, contributing to both pre-market and post-market activities.
This role guides cross-functional teams on global regulatory requirements, ensures documentation is ready for regulatory submissions, and evaluates product and process changes.
The position serves as a primary liaison between global regions and R&D teams to address regulatory inquiries, resolve issues, and provide technical support.
Matching Summary
Match Score: 85
Cochlear is seeking a Senior Regulatory Affairs Specialist in Kuala Lumpur, Malaysia, to provide regulatory support throughout the lifecycle of its medical devices. The role involves guiding teams on regulatory requirements, managing submissions, and collaborating with cross-functional teams to ensure compliance.
Skills & Requirements
Must-have
Global regulatory requirements
Product lifecycle support
Cross-functional team guidance
Regulatory submissions and maintenance
Nice-to-have
Influence and collaborate effectively
Stakeholder management
Sound judgment and decision-making
Build effective relationships with regulators
Key Requirements
Bachelor’s degree in engineering, legal, scientific, or healthcare discipline
3-5+ years’ experience in product development, quality, or regulatory affairs
3+ years’ experience in regulatory affairs, including preparation, submission, and maintenance of regulatory filings
3+ years’ experience in medical-device product or software development
Knowledge of global medical-device regulatory requirements