Sr RA Specialist, APAC Indirect Mkts

Intuitive; Malaysia; On-site; MYR 90,000 - 130,000; Full time

Job summary

Intuitive seeks a Regulatory Affairs professional to lead regulatory strategy for medical device registrations in APAC indirect markets. The role coordinates with Distributor RA to assemble regulatory documentation, maintain licenses and manage change control while ensuring compliance with evolving regulations.

Experience with ISO13485 and related quality systems is preferred. Strong communication and teamwork across BU RAs, Commercial, and PMO are essential to support business objectives.

Qualifications

• Bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences.
• Knowledge of ISO13485, GDPMDS or similar quality management system requirements and broad understanding of what it takes to work in a regulated environment.

Responsibilities

• Execute regulatory plans for medical device registrations in APAC indirect markets.
• Coordinate with Distributor RAs and Intuitive stakeholders to ensure compliance with medical device regulations in APAC indirect markets.
• Determine types of regulatory submissions or internal documentation required during new product submissions, changes, notifications, etc.
• Input and manage regulatory submission tracking information in Intuitive's regulatory databases.
• Compile high quality submissions meeting technical requirements from regulatory authorities.
• Perform periodic regulatory surveillance and impact assessments using TrackWise.
• Support other teams in ensuring regulatory compliance as required.
• Perform other tasks as assigned.

Education

Bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences

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 approval, change management and license renewals, while supporting business objectives.

Together with the Distributor RAs, determine the types of regulatory submissions or internal documentation required during new product submissions, change submission/variation/notifications etc.

Input and manage regulatory submission tracking information maintained in Intuitive's regulatory database/systems (Veeva, PRDb, Agile, Smartsheet etc.).

Compile high quality submissions meeting technical requirements from regulatory authorities.

Perform periodic regulatory surveillance activities (e.g. new/upcoming regulations) and necessary impact assessments (RSA) using TrackWise.

Support other teams in ensuring regulatory compliance, as required.

Perform other tasks as assigned.

Organizational and planning skills, including action orientation, focused urgency and driving for results.

Good team player, ability to collaborate and influence others.

Excellent interpersonal skills.

Required Education and Training

At least a bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences.

Knowledge of ISO13485, GDPMDS or similar quality management system requirements and broad understanding of what it takes to work in a regulated environment.

Preferred Skills and Experience

Experience with Agile, Veeva, TrackWise or similar regulatory information management systems.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

This position may be filled at a different job level than listed here depending

business need and/or on the selected candidate's experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.