Deskripsi Pekerjaan
Join Edwards Lifesciences in Kuala Lumpur and play a pivotal role in our global compliance strategy. As a leader in medical technology, we are dedicated to improving patient outcomes through innovative therapies. In this Senior Representative, Labeling role, you will ensure that our product labeling meets rigorous international standards and regulatory requirements.
You will manage the end-to-end lifecycle of labeling deliverables, ensuring accuracy and timeliness from draft to final approval. Your expertise will drive process improvements that enhance efficiency and regulatory adherence across the organization. This is an exciting opportunity for a detail-oriented professional to impact patient safety and regulatory excellence within a world-class organization.
Tanggung Jawab
- Oversee updates and changes to global labeling standards, procedures, and templates to ensure compliance with international regulations.
- Manage the routing and approval process for all labeling deliverables, coordinating with cross-functional teams including R&D, Regulatory Affairs, and Legal.
- Develop and deliver comprehensive training plans to ensure internal stakeholders are proficient in labeling protocols and procedures.
- Identify and implement process improvements to increase efficiency and reduce turnaround time for labeling projects.
- Monitor regulatory changes and industry trends to recommend necessary updates to labeling content.
- Maintain accurate records and documentation of labeling changes for audit and compliance purposes.
- Collaborate with regional teams to ensure alignment with global labeling strategies.
Kualifikasi
- Bachelor’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related field.
- Minimum of 5-7 years of experience in labeling, regulatory affairs, or medical device compliance.
- Strong working knowledge of global labeling standards, including ICH Q5E, FDA CFR 21 Part 201, and EMA guidelines.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Detail-oriented with strong analytical problem-solving abilities and attention to accuracy.
- Proficiency in using labeling management systems (LIMS) and Microsoft Office Suite.
- Ability to work effectively in a fast-paced, multi-cultural, and dynamic environment.