Senior Regulatory Affairs Specialist

4 days ago


Singapur, Singapore Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Experienced inmedical devices

With direction, develop and execute regulatory project plans

Identify and elevate key areas of regulatory risk

Maintain current knowledgeof international regulatory requirements, guidance and standards applicable to company products

Participate as an active team member and provide regulatory advice to project teams as required

Respond to questions from regulatory authorities within strict timelines

Compile and submit, in a timely manner, regulatory documents according to regulatory requirements

Maintain and update existing regulatory authorizations

Support regulatory activities relating to specific portfolio of products/projects

Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations

Prepare SOPs to reflect specific local requirements.

Review advertisement and promotional literature when needed

Represent or lead Regulatory Affairs in small project teams

Provide guidance to junior team members when needed

Perform other duties as assigned

Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).

Oversee documentation to ensure completion of records and GDP Compliance

Prepares SOP, Document Change Request (DCRs) and Periodic Review.

Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS (GDP for Medical Devices) standards.



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