job description
Join Haemonetics as a Senior Labeling Specialist and play a pivotal role in ensuring compliance and accuracy in product labeling and artwork. This position offers a unique opportunity to leverage your expertise in regulatory requirements and labeling systems while collaborating with cross-functional teams to deliver high-quality medical products. Based in the vibrant regions of Bali, you will contribute to maintaining our commitment to excellence in healthcare solutions.
As a Senior Labeling Specialist, you will be responsible for developing, reviewing, and maintaining compliant product labels and artwork in accordance with global regulatory standards. Your role will involve close collaboration with R&D, Quality Assurance, and Regulatory Affairs teams to ensure all labeling materials meet the highest standards of accuracy and compliance. If you are detail-oriented, possess strong analytical skills, and have a passion for regulatory compliance, this role is perfect for you.
Haemonetics is a global leader in blood management and patient safety solutions. We are dedicated to improving patient care and reducing healthcare costs through innovative technologies. Join our team and be part of a mission-driven organization that values integrity, collaboration, and excellence.
Responsibility
- Develop and maintain compliant product labels and artwork in accordance with global regulatory standards.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to ensure labeling accuracy and compliance.
- Review and approve labeling changes, ensuring alignment with company policies and regulatory requirements.
- Manage and maintain labeling systems, ensuring data integrity and accessibility.
- Provide expert guidance and training on labeling processes and regulatory requirements to internal stakeholders.
- Conduct regular audits of labeling materials to identify and address potential compliance issues.
- Stay updated on changes in regulatory requirements and industry best practices related to product labeling.
- Support the preparation and submission of regulatory documentation related to product labeling.
Qualifications
- Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or a related discipline).
- Minimum of 5 years of experience in product labeling, regulatory affairs, or a related field within the medical device or pharmaceutical industry.
- Strong knowledge of global regulatory requirements for product labeling (e.g., FDA, EU MDR, ISO standards).
- Experience with labeling software and systems (e.g., PLM, ERP, or similar tools).
- Excellent attention to detail and strong analytical skills.
- Proven ability to work collaboratively in a cross-functional team environment.
- Strong communication skills, with the ability to convey complex regulatory information clearly and effectively.
- Certification in regulatory affairs or related fields is a plus.