Senior APAC Regulatory Affairs Specialist (Remote)

Intuitive

Kuala Lumpur

Remote

MYR 120,000 - 180,000

Full time

4 days ago

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Job summary

Intuitive Surgical in Kuala Lumpur offers a remote-friendly Regulatory Affairs role focused on APAC indirect markets. The primary function is to develop and execute regulatory strategies to obtain registration approvals for the portfolio, coordinate with Distributor RA, and ensure ongoing compliance.

You will interact with BU RAs, Commercial, PMO and other stakeholders while staying aligned with ISO13485 and GDPMDS requirements.

Qualifications

Bachelor’s degree in Medical Technology, Life Sciences, Pharma or similar sciences.
Knowledge of ISO13485, GDPMDS or similar quality management system requirements.
Experience with Agile, Veeva, TrackWise or similar regulatory information management systems.

Responsibilities

Execute regulatory strategy for registration approvals of Intuitive’s portfolio.
Coordinate with Distributor RA to compile regulatory documentation.
Evaluate medical device changes and ensure regulatory compliance.
Work with Intuitive BU RAs to plan registrations in APAC indirect markets.
Communicate with Distributor RAs and stakeholders to ensure regulatory compliance.
Determine submission types and required internal documentation with Distributor RAs.
Input and manage regulatory submission tracking in regulatory databases.
Compile high quality submissions meeting regulatory requirements.
Perform regulatory surveillance and impact assessments.
Support other teams in regulatory compliance as needed.