Job Summary:
Vantive is hiring a Senior Specialist, Regulatory Affairs & Quality Assurance (RA & QA) in Singapore to lead regulatory strategies for medical devices and therapeutic products. This role requires handling product registration, regulatory submissions, renewals, and ensuring adherence to local and global quality systems. As a key point of contact with regulatory agencies, you will also assist in implementing quality systems, managing field actions, and maintaining regulatory compliance, making a significant impact on healthcare product safety and market continuity.
Key Responsibilities:
Develop and implement regulatory strategy for medical devices and therapeutic products.
Compile and submit new product registrations, variations, renewals, and change notifications.
Ensure labeling aligns with Company Core Data Sheets and regional regulations.
Manage and maintain regulatory databases and reports for accuracy and compliance.
Monitor approved product files for ongoing regulatory compliance.
Evaluate amendments or changes and take appropriate regulatory actions.
Collaborate with cross-functional teams to support regulatory and market objectives.
Serve as primary contact with local Regulatory Agency for submissions and approvals.
Handle change control activities and support execution of local/global change strategies.
Support quality system procedures, including audits, complaints, field actions, and post-market surveillance.
Assist with product release and quality operations related to Field Action activities.
Required Skills & Qualifications:
Bachelor’s degree in Science or Pharmacy (B.Sc. or B-Pharm preferred).
Minimum 4 years of experience in the medical device industry.
Experience in pharmaceutical registration is an advantage.
Familiar with product registration, license extensions, variations, and renewals.
Ability to communicate, negotiate, and persuade effectively.
Strong multi-tasking and organizational skills in fast-paced settings.
Flexible, adaptable to change, and self-motivated team player.
Registered Pharmacist with Singapore Pharmacy Council (advantageous).
Perks & Benefits:
Opportunity to lead regulatory and quality assurance functions in a globally recognized healthcare company.
Exposure to medical device and pharmaceutical registration processes.
Collaborative work environment with cross-functional teams.
Career development in vital organ therapy innovations.
Equal opportunity employer with inclusive workplace policies.
Company Description:
Vantive is a global leader in vital organ therapies, pioneering innovation in kidney care and expanding into broader medical technologies. With over 70 years of excellence, Vantive is committed to delivering advanced healthcare solutions to improve patient lives worldwide.
Work Mode:
On-site – Singapore, Singapore.
Call to Action:
Elevate your regulatory and quality assurance career with Vantive. Apply now to shape the future of medical device and therapeutic product compliance in Singapore.
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