Sr. RA Specialist

Primary Function of Position
The position is responsible for the product registration strategies set up and execution of them. This position is also responsible for new product approvals and maintenance of the approved product licenses via timely renewals re-registrations.

Essential Job Duties
Product registration
o Understand regulatory requirements and medical device regulations.
o Spearhead all procedures of product registration amendment and administrative
work precisely and efficiently including planning compiling registration submission
filing documents related and data archiving reports etc.
o Provide input on the product registration status and results to function head as well
as stakeholders within ISI & IST to help their planning and business of the company.
o Assess the product changes and develop regulatory strategy to implement the
change on time.
o Obtaining regulatory approval for new products renewal and amendment on time.
o Reporting the information to government according to relevant Taiwan Medical
Device regulations.
o Manage SAP Veeva-RIM regulatory database.
o Validate the content of approved labeling to ensure compliance with the relevant local
Act and regulations for local labeling.
o Closely communicate with regulatory agencies and global counterparts to seek
resolutions on regulatory issues.
o Ensures adherence to standard operating procedures and working instructions for the
rapid and timely approval of new medical devices and regulatory support of marketed
products.
o Provide RA input for cross-functional projects including but not limited to the clinical
trial market access etc.
o Actively participate in various RA&QA projects internally and externally.
o Participate in continuous training programs held by TFDA. Training hours and
categories shall be taken in accordance with Regulations for Management of Medical
Devices Technicians.
Regulatory intelligence & surveillance
o Work closely with industry associations to build advocacy for Intuitive.
o Provide input to the global Regulatory Standard team on the local regulatory
environmental changes to evaluate the impact and implement the necessary action in
a timely manner.
o Review the promotional materials to ensure the compliance to local medical devices
regulations and internal guidelines.
QMS management
o Participate in internal and external audits as an auditee for regulatory affairs.
Implement post audit activities and CAPA follow-up & closure for regulatory affairs
related matters.

Qualifications :

Required Skills and Experience
Knowledge of Taiwan medical device act & regulations ISO13485.
Preferred >9 years of relevant RA experience in the medical device industry.
Proven ability to review and translate technical documentation into effective regulatory
submissions.
Strategic thinking skill.
Passionate and a great sense of responsibility.
Good communication & interpersonal skill to work well with cross-functional teams.
Excellent written and verbal communication skills in both Chinese and English command.

Required Education and Training
Bachelors degree in science engineering medical technology life sciences or similar is
required.
Completed at least 20 hours of education and training in the past five years on the
following topics:
o Domestic laws and regulations related to medical devices.
o Quality management system related to medical device manufacturing.
o Document preparation and process management for registration and market
approval.
o Submission for registration and market approval.
o Post-market surveillance of medical devices.

Working Conditions
None

Preferred Skills and Experience
Experience in Agile SAP

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. 

Remote Work :

No

Employment Type :

Full-time