Sr. RA Specialist

Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.Job DescriptionPrimary Function of PositionThe 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 DutiesProduct registrationUnderstand regulatory requirements and medical device regulations.Spearhead all procedures of product registration, amendment, and administrativework precisely and efficiently, including planning, compiling registration submission,filing documents related and data archiving, reports, etc.Provide input on the product registration status and results to function head as wellas stakeholders within ISI & IST to help their planning and business of the company.Assess the product changes and develop regulatory strategy to implement thechange on time.Obtaining regulatory approval for new products, renewal, and amendment on time.Reporting the information to government according to relevant Taiwan MedicalDevice regulations.Manage SAP, Veeva-RIM regulatory database.Validate the content of approved labeling to ensure compliance with the relevant localAct and regulations for local labeling.Closely communicate with regulatory agencies and global counterparts to seekresolutions on regulatory issues.Ensures adherence to standard operating procedures and working instructions for therapid and timely approval of new medical devices and regulatory support of marketedproducts.Provide RA input for cross-functional projects, including but not limited to the clinicaltrial, market access, etc.Actively participate in various RA&QA projects internally and externally.Participate in continuous training programs held by TFDA. Training hours andcategories shall be taken in accordance with Regulations for Management of MedicalDevices Technicians.Regulatory intelligence & surveillanceWork closely with industry associations to build advocacy for Intuitive.Provide input to the global Regulatory Standard team on the local regulatoryenvironmental changes to evaluate the impact and implement the necessary action ina timely manner.Review the promotional materials to ensure the compliance to local medical devicesregulations and internal guidelines.QMS managementParticipate in internal and external audits as an auditee for regulatory affairs.Implement post audit activities and CAPA follow-up & closure for regulatory affairsrelated matters.QualificationsRequired Skills and ExperienceKnowledge 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 regulatorysubmissions.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 TrainingBachelor's degree in science, engineering, medical technology, life sciences or similar isrequired.Completed at least 20 hours of education and training in the past five years on theFollowing TopicsDomestic laws and regulations related to medical devices.Quality management system related to medical device manufacturing.Document preparation and process management for registration and marketapproval.Submission for registration and market approval.Post-market surveillance of medical devices.Working ConditionsNonePreferred Skills And ExperienceExperience in Agile, SAPAdditional InformationIntuitive 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 CFR743.13(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.Shift:Day