Global Regulatory Affairs Lead, Medical Devices (Remote)
Lead global regulatory submissions for medical device product launches
Define regulatory strategies to enable timely product registrations and ongoing compliance across global markets. Partner with R&D, Quality, Clinical, Manufacturing, Service, and Marketing teams in Asia Pacific and other regions to support product launches and post-market activities. Lead regulatory submissions, maintain technical documentation, and monitor evolving regulatory requirements to ensure compliant development and market access.
Why This Role?
Partner with cross-functional teams across Asia Pacific and global markets on product launches
Key Responsibilities
- Define regulatory strategies for global product registrations and compliance
- Partner with R&D, Quality, Clinical, Manufacturing, Service, and Marketing teams
- Lead regulatory submissions for product launches in Asia Pacific and other markets
- Maintain and update technical documentation for medical devices
- Monitor evolving regulatory requirements across global markets
- Support post-market activities to ensure ongoing compliance
Requirements
- Experience in regulatory affairs for medical devices
- Ability to partner with R&D, Quality, Clinical, Manufacturing, Service, and Marketing teams
- Experience leading regulatory submissions
- Knowledge of global regulatory requirements and evolving standards
- Experience maintaining technical documentation
- Experience supporting product launches and post-market activities
Required Skills
Indonesia Context
- Working Hours Overlap:
- Flexible — work your own hours
View Original Description from AdzunaShow more
Original description from Adzuna
Accuray is seeking a Senior Regulatory Affairs Specialist to expand global reach by defining regulatory strategies that enable timely registrations and ongoing compliance. You will partner with R&D, Quality, Clinical, Manufacturing, Service, and Marketing across Asia Pacific and other markets to support product launches and post-market activities. You will lead regulatory submissions, maintain technical documentation, and monitor evolving regulatory requirements to ensure compliant development,…
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