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RA Specialist

Company

Intuitive

Location

Kuala Lumpur, Federal Territory of Kuala Lumpur

Type

full-time

Job Description

Primary Function of Position 

• Execute the regulatory strategy for obtaining registration approval of Intuitive’s portfolio,

according to plan.

• With limited supervision, coordinate with Distributor RA to compile regulatory documentation

for submission to regulatory authorities, maintenance of licenses and change management.

• Evaluate medical device changes, determine and execute regulatory strategy and ensure

compliance.



Essential Job Duties

• Work closely with respective Intuitive BU RAs to execute

regulatory plans for medical device registrations in APAC

indirect markets.

• Communicate with Distributor RAs and Intuitive’s stakeholders

(BU RAs, Commercial, PLO, PMO, Hardware Compliance etc.) to ensure compliance with the

relevant medical device regulations in APAC indirect markets, including requirements for

ap...

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