Is Global Regulatory Affairs Lead, Medical Devices (Remote) at Accuray a remote job?

Yes. Global Regulatory Affairs Lead, Medical Devices (Remote) at Accuray is a fully remote role open to candidates worldwide.

Click the "Apply" button on this page to go to the official application at Accuray.

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Accuray

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

regulatory affairscompliancecommunicationproject managementRegulatory StrategyMedical Device ComplianceCross-functional CollaborationTechnical DocumentationGlobal SubmissionsPost-market Surveillance

Indonesia Context

Working Hours Overlap:: Flexible — work your own hours

See remote (USD) vs local pay →

View Original Description from Adzuna

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,…

Salary Context

Similar Marketing roles on LokerDollar pay around $175k/yr (range $10k–543.478k/yr, n=242 active listings).

For you

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Company

Accuray

Source

Adzuna

Job Type

full time

Location

Remote · Madison, USA

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Frequently asked questions

Is Global Regulatory Affairs Lead, Medical Devices (Remote) at Accuray a remote job?: Yes. Global Regulatory Affairs Lead, Medical Devices (Remote) at Accuray is a fully remote role open to candidates worldwide.
What type of employment is Global Regulatory Affairs Lead, Medical Devices (Remote) at Accuray?: This is a full time position.
How do I apply?: Click the "Apply" button on this page to go to the official application at Accuray.