Senior Specialist, RA & QA

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:

• Responsible for the development and implementation of the regulatory strategy for medical devices and therapeutic products.
• Compile, prepare and submit new registration, variations, change notifications, renewals and ensure approvals in a timely manner.
• Ensure product labeling is in line with Company Core Data Sheet and country regulations.
• Learn, drive and manage various databases and reports ensuring information is accurate and up to date. Maintain regulatory files in a format consistent with requirements.
• Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions.
• Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity.
• Serve as a key contact person for regulatory affairs and be the regulatory knowledge source for the cross-functional team.
• Communicate and, if necessary, negotiate with the country Regulatory Agency to support key submissions/projects.
• Manage change controls and create strategies to support the execution and implementation of changes required by local or global
• Assist in implementing the quality systems procedures and participate in quality related activities e.g. internal and external audits, product complaint, field action, post-market surveillance, change control
• Assist in quality operation activities related to Field Action (FA) such as customer notification letters, product on hold and product recall activities.
• Assist in product release

Qualifications:

• Well-versed with new registration, license extensions, variations and renewals. Solid experience in medical device registration. Experience with pharmaceutical product registration is an advantage
• Ability to communicate effectively, negotiate and persuade.
• Ability to multi-task effectively in a fast-paced environment.
• Ability to keep tight deadlines and work under pressure.
• Flexibility and ability to adapt to change.
• Good team player and self-motivated.

Education and/or Experience:

• B.Sc.or B-Pharm(preferred)
• Minimum 4 years of relevant experience in medical device industry
• Experience with pharmaceutical registration is an advantage

Registered pharmacist with Singapore Pharmacy Council is an advantage

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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