Intuitive
medical device
Sr.RASpecialist
“Sr. RA Specialist at Intuitive. Skills: Product registration strategies and execution, Medical device regulations, Regulatory submissions, Regulatory intelligence and surveillance, QMS management. Product registration strategies set up and execution. New product approvals”
What You'll Achieve.
Spearhead all procedures of product registration, amendment, and administrative work precisely and efficiently; Obtaining regulatory approval for new products, renewal, and amendment on time; Ensure adherence to standard operating procedures and working instructions for the rapid and timely approval of new medical devices and regulatory support of marketed products; Implement necessary action in a timely manner
Industry & Context.
Seek resolutions on regulatory issues; Assess the product changes and develop regulatory strategy
What They're Looking For.
Must Have
Knowledge of Taiwan medical device act & regulations, Knowledge of ISO13485, 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, Bachelor’s degree in science, engineering, medical technology, life sciences or similar, Completed at least 20 hours of education and training in the past five years on the following topics: Domestic laws and regulations related to medical devices, Quality management system related to medical device manufacturing, Document preparation and process management for registration and market approval, Submission for registration and market approval, Post-market surveillance of medical devices
Nice to Have
>9 years of relevant RA experience in the medical device industry
What You'll Do.
Product registration strategies set up and execution
New product approvals
Maintenance of approved product licenses via timely renewals
Spearhead all procedures of product registration
and administrative work precisely and efficiently
Provide input on the product registration status and results to function head as well as stakeholders
Assess the product changes and develop regulatory strategy to implement the change on time
Obtaining regulatory approval for new products
and amendment on time
Reporting the information to government according to relevant Taiwan Medical Device regulations
Veeva-RIM regulatory database
Validate the content of approved labeling to ensure compliance with the relevant local Act and regulations for local labeling
Closely communicate with regulatory agencies and global counterparts to seek resolutions on regulatory issues
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
Provide RA input for cross-functional projects
Actively participate in various RA&QA projects internally and externally
Participate in continuous training programs held by TFDA
Work closely with industry associations to build advocacy for Intuitive
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
Review the promotional materials to ensure the compliance to local medical devices regulations and internal guidelines
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
How You'll Work.
Team & Collaboration
Work well with cross-functional teams; Provide input on the product registration status and results to function head as well as stakeholders within ISI & IST; Closely communicate with regulatory agencies and global counterparts; Provide RA input for cross-functional projects; Actively participate in various RA&QA projects internally and externally; Work closely with industry associations; Provide input to the global Regulatory Standard team
Communication Scope
Good communication & interpersonal skill; Excellent written and verbal communication skills in both Chinese and English command
Process & Methodology
Planning, Compiling registration submission, Filing documents, Data archiving, Reports, CAPA follow-up & closure
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