Regulatory Affairs Professional

Vantive is a vital 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.

Our goal is to deliver greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients.

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 by contributing your expertise as a Regulatory Affairs Specialist.

Key Responsibilities:

Develop and implement regulatory strategies 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.

Manage databases and reports to ensure information is accurate and up-to-date.

Maintain regulatory files in a format consistent with requirements.

Conduct regulatory monitoring of approved products and ensure maintained files are current.

Evaluate the effects of an amendment or change and take appropriate regulatory actions.

Work collaboratively with cross-functional teams to ensure regulatory compliance and market continuity.

Serve as a key contact person for regulatory affairs and be the regulatory knowledge source for cross-functional teams.

Communicate and negotiate with country Regulatory Agencies to support key submissions/projects.

Manage change controls and create strategies to support the execution and implementation of changes required by local or global regulatory bodies.

Assist in implementing quality systems procedures and participate in quality-related activities, such as internal and external audits, product complaints, field actions, post-market surveillance, and change control.

Assist in quality operation activities related to Field Actions (FA) such as customer notification letters, product on hold, and product recall activities.

Assist in product release.

Requirements:

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.

Qualifications:

Bachelor's degree in Pharmacy (preferred).

Minimum 4 years of relevant experience in the medical device industry.

Experience with pharmaceutical registration is an advantage.

Registered pharmacist with the Singapore Pharmacy Council is an advantage.

Reasonable Accommodation:

For individuals with disabilities requiring reasonable accommodations during the application or interview process, please provide details along with contact information.

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