RA Specialist

Primary Function of Position 
Execute the regulatory strategy for obtaining registration approval of Intuitives 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 Intuitives 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 Intuitives
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.

Qualifications :

Required Skills and Experience
5 10 years of experience in medical devices registration in ASEAN countries.
Computer literacy (PC Microsoft Word/Excel/PowerPoint Outlook).
Fluent in written and spoken English.
Detail-oriented
Ability to multi-task prioritize and schedule work to meet reporting or other deadlines.
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 bachelors 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.

Additional Information :

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 employeeswho 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 governments 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 employeesstart 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 on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

Remote Work :

Yes

Employment Type :

Full-time