Senior RA Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Serves as the core-team member for regulatory affairs function.
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies.
• Responsible for license renewal of products.
• Responsible for related Legal manufacturer and Local agent and MDR IFU change variation submissions of products.
• Responsible for change submissions of products.
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Review IFUs and labels of products listed above for compliance with regulatory requirements.
• Review PR changes to existing products above listed to define the requirements for regulatory submissions.
• Support and review PRER for products listed above.
• Maintain current knowledge of NMPA and international regulation, guidance and standards applicable to company products.
• Oversee and maintain vigilance on regulatory issues and disseminate regulatory information to relevant QA, R&D department and senior management as required.
• Serves as the support for regulatory, guidance and standards related matters for BU customers.
• Help to ensure compliance to the Quality Management System.
• Support internal audits and Quality Management Review. Provide Regulatory Affairs support for external audits and inspections.
• Other duties as assigned

QUALIFICATIONS AND SKILLS:

• Bachelor’s degree or above in medical related discipline.
• With minimum of at least 4 years’s RA experience. (Master’s degree with 6 years relevant experience within the QA and RA)
• Experience with Class II & Class III devices.
• Regulatory Affairs Certification desired, work in multinational/international company experience is a plus.
• Regulatory knowledge and Scientific Knowledge.
• Ability to define problems, analyze data, establish facts and draw conclusions

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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