Senior Regulatory Affairs Specialist – Greater Asia

Baxter International Inc.•Southern Gateway, VA

30d

About The Position

Join Baxter’s Regulatory Affairs team and make a direct impact on how innovative medical devices reach patients safely across Greater Asia. In this role, you’ll design and implement regulatory strategies, secure product approvals, and ensure compliance with evolving requirements. You’ll be hands‑on in shaping Baxter’s portfolio, working across new product development, post‑market activities, and regional projects—all while building your expertise and influence in a dynamic healthcare environment.

Requirements

A degree in Pharmacy, Health Sciences, or equivalent.
Minimum 5 years of regulatory experience in medical devices.
Proven expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above.
Strong knowledge of regulatory laws, acts, and evolving requirements.
Solid understanding of GDPMD standards.
Skills in project management, multitasking, and prioritization.
Excellent interpersonal, communication, and negotiation abilities.
Proficiency in technical systems (word processing, spreadsheets, databases, online research).
Ability to identify compliance risks and escalate effectively.

Nice To Haves

Experience with RIM systems is an advantage.

Responsibilities

Develop and execute project plans that keep approvals on track.
Identify and escalate regulatory risks early, ensuring proactive solutions.
Stay ahead of international regulatory requirements and translate them into clear, actionable steps.
Be an active contributor on project teams, offering practical regulatory advice.
Respond to regulatory authority inquiries within strict timelines.
Compile, prepare, and submit registrations, renewals, variations, and change notifications to secure timely approvals.
Review and approve labeling and promotional materials for compliance.
Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards.
Manage post‑market surveillance, field actions, and complaints in Singapore and Malaysia.
Own regulatory databases and reporting, ensuring accuracy and transparency.
Share regulatory intelligence with business units, strengthening collaboration and decision‑making.
Support continuous improvement initiatives, including process optimization and digitization.
Participate in audits and ensure documentation control, GDP compliance, and record retention.
Take on additional responsibilities that broaden your expertise and support regulatory excellence.