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Summary
- This role offers an exciting opportunity to provide regional regulatory support for new product development and post‑market activities within Baxter’s medical device portfolio. You will be hands‑on in shaping regulatory strategies, ensuring smooth product registrations, and keeping pace with evolving requirements. From new registrations and renewals to post‑approval changes and stakeholder engagement, you’ll play a critical role in enabling Baxter’s 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 post‑market 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 decision‑making.
- Support continuous improvement initiatives, including process optimization and digitization within Regulatory Affairs.
- Perform additional duties as assigned to support regulatory excellence.
Education & Experience
- Bachelor’s 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.
- In‑depth 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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