Deskripsi Pekerjaan
Join Baxter Healthcare as a Senior Specialist in Regulatory Affairs & Quality Assurance (RAQA) and drive excellence in regulatory compliance and quality standards. In this pivotal role, you will implement robust regulatory strategies and quality management systems to ensure our healthcare products meet global safety and efficacy standards. You'll navigate complex regulatory landscapes, obtain and maintain essential approvals, and champion continuous improvement initiatives that align with industry best practices. Collaborate with cross-functional teams to mitigate risks, ensure compliance with local and international regulations, and support product lifecycle management from development to post-market surveillance. Your expertise will directly impact patient safety and regulatory compliance across Baxter's portfolio.
This position offers the opportunity to work in a dynamic healthcare environment where your regulatory expertise will shape product approvals, quality audits, and compliance frameworks. You'll be instrumental in maintaining Baxter's reputation for quality and regulatory excellence while contributing to innovations that improve patient outcomes. If you're passionate about regulatory mastery and quality-driven processes, this role offers a platform to make significant contributions to global healthcare standards.
Tanggung Jawab
- Lead local implementation of regulatory strategies and quality management systems for assigned products/markets
- Obtain and maintain regulatory approvals (MDA, FDA, EMA) through submissions and dossiers
- Conduct quality risk assessments and implement corrective/preventive actions
- Manage regulatory compliance audits and inspections, ensuring timely resolution of findings
- Monitor regulatory changes and assess impact on product portfolio and operations
- Collaborate with global teams to harmonize regulatory approaches and quality standards
- Develop and maintain regulatory documentation and quality procedures
- Represent RAQA in cross-functional project teams and quality reviews
Kualifikasi
- Bachelor's degree in Pharmacy, Life Sciences, Engineering, or related field; Master's preferred
- Minimum 5 years' experience in regulatory affairs or quality assurance within healthcare/medical devices
- Expert knowledge of local (MDA) and international regulatory requirements (FDA, EU MDR)
- Proven experience with quality management systems (QMS), GMP, and ISO standards
- Certification in Regulatory Affairs (RAC) or Quality Management (CQM) highly desirable
- Strong project management skills with ability to handle multiple priorities
- Excellent analytical and problem-solving abilities in regulatory compliance contexts
- Proficient in regulatory submission preparation and electronic document management