Senior Regulatory Affairs Specialist – Regional

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At Baxter we believe every personregardless of who they are or where they are fromdeserves 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.

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Summary

• This role offers an exciting opportunity to provide regional regulatory support for new product development and postmarket activities within Baxters medical device portfolio. You will be handson in shaping regulatory strategies ensuring smooth product registrations and keeping pace with evolving requirements. From new registrations and renewals to postapproval changes and stakeholder engagement youll play a critical role in enabling Baxters innovations to reach patients safely and compliantly across the region.

Essential Duties & Responsibilities

• Develop and execute regulatory project plans that keep products moving efficiently through approval pathways.
• Identify and escalate regulatory risks early ensuring proactive solutions.
• Stay ahead of evolving regulations and translate requirements into clear actionable steps.
• Maintain accurate and compliant regulatory files and documentation.
• Actively contribute to project teams offering practical regulatory guidance.
• Respond to inquiries from regulatory authorities within strict timelines.
• Compile prepare and submit new registrations variations renewals and change notifications to secure timely approvals.
• Review and approve labeling and promotional materials to ensure compliance with local regulations.
• Represent Regulatory Affairs in project teams supporting business objectives and compliance standards.
• Manage postmarket surveillance (PMS) field actions and complaints in Singapore and Malaysia.
• Own and manage regulatory databases and reporting ensuring accuracy and transparency.
• Provide regulatory intelligence to business units strengthening collaboration and decisionmaking.
• Support continuous improvement initiatives including process optimization and digitization within Regulatory Affairs.
• Perform additional duties as assigned to support regulatory excellence.

Education & Experience

• Bachelors Degree in Pharmacy Science or equivalent.
• Minimum 6 years of regulatory experience in the medical devices industry.
• Strong expertise in new registrations license extensions variations and renewals with mandatory experience in Class II devices and above.
• Indepth knowledge of regulatory laws acts and evolving requirements.
• Solid understanding of GDPMD standards.
• Skilled in project management multitasking and prioritization.
• Excellent interpersonal communication and negotiation skills.
• Proficiency in technical systems (word processing spreadsheets databases online research).
• Ability to identify compliance risks and escalate effectively.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter 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.

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