Baxter
Healthcare
SeniorSpecialist,RAQA
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“Senior Specialist, RAQA at Baxter. Skills: Regulatory affairs, Quality assurance, Medical devices, Pharmaceuticals. Implement regulatory and quality activities. Obtain and maintain marketing authorizations”
Industry & Context.
Root cause analysis; Identify compliance risks
What They're Looking For.
Must Have
At least 5 years of relevant experience in pharmaceutical, biologics and medical devices in Malaysia, Regulatory and quality experience (within a healthcare environment), Well-versed with new registration, license extensions, variations and renewals in Malaysia, Knowledge of applicable regulatory laws and acts, Knowledge of regulations and well-versed with changing scope and evolving regulations, Good understanding of GDPMD, Manage multiple projects and deadlines, Ability to multitask and prioritize, Ability to identify compliance risks and escalate when necessary
Nice to Have
Degree in pharmacy, science or related discipline is an advantage, Pharmacist License is an advantage, Experience with both drugs and medical device registration is an advantage
What You'll Do.
Implement regulatory and quality activities
Obtain and maintain marketing authorizations
Communicate local regulatory requirements
Develop and execute regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain awareness of regulatory requirements
Provide regulatory advice to project teams
Respond to questions from regulatory authorities
Compile and submit regulatory documents
Maintain and update existing regulatory authorizations
Support regulatory activities for products/projects
Review AdProm materials for compliance
Prepare SOPs for local requirements
Represent Regulatory Affairs in project teams
Provide guidance to junior team members
Perform other duties as assigned
Act as designated person /QMR for GDPMD
Manage product complaint related matters
Ensure procedure compliance for non-conformances
Manage product recalls
Ensure product complaint reporting compliance
Investigate returned samples for root cause
Follow-up on potential Medical or Adverse Event product
follow-up and trend product complaints
Manage FA related actions
Issue customer notification letters
Perform regulatory reporting for FA
Manage product recall activities
Reply to customer complaints
Address customer queries related to quality
Present quality information to customers
Release Finished Goods with temperature control
Release Finished Goods after routine redressing
Manage redressing instruction
Control and maintain documentation
Maintain records and ensure record retention
Ensure compliance with Good Documentation Practices (GDP)
Ensure compliance with Standard Operating Procedures (SOPs)
Oversee documentation for completion and GDP Compliance
Prepare Document Change Requests (DCRs)
Prepare Periodic Reviews
Ensure compliance with SOPs
Ensure compliance with quality assurance
Ensure compliance with internal regulations
Ensure compliance with local regulations
Ensure compliance with GDPMDS standards
Manage internal audits
Manage external audits
Manage supplier audits
Manage suppliers with support of supplier quality
Assist with data gathering for Quality Reviews
Assist with data analysis for Quality Reviews
Assist with data gathering for Complaints
Assist with data analysis for Complaints
How You'll Work.
Team & Collaboration
Active team member; Represent Regulatory Affairs; Provide guidance to junior members
Process & Methodology
Project management, Manage multiple projects, Prioritize tasks
Full Job Description
**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. **Summary** Under limited supervision responsible for the local implementation of regulatory and quality activities and strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of drugs, biologics and medical devices products. **Essential Duties & Responsibilities** * Strong experience in drugs and biologics * Relevant experience in medical devices in Malaysia * With direction, develop and execute regulatory project plans * Identify and elevate key areas of regulatory risk * Maintain awareness of regulatory requirements; identify relevant requirements * 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.
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