Communication Skills, Cross-Functional, Detail Oriented, FDA Requirements, International Operations, Maintain Compliance, Manufacturing, Manufacturing Requirements, Manufacturing/Industrial Processes, Medical Equipment, Operational Strategy, Operational Support, Organizational Skills, Process Development, Process Improvement, Regulatory Compliance, Regulatory Requirements, Time Management
We are seeking a detail-oriented Global Trade Operations Specialist to support global trade and labeling operations within the medical device industry. This role requires strong cross-functional collaboration, compliance expertise, and a solid understanding of labeling and manufacturing processes. Responsibilities:
- Support global trade operations, ensuring adherence to international regulations and company policies.
- Coordinate and manage labeling activities, including Labeling Management Database (LMD) processes.
- Collaborate with cross-functional teams and stakeholders to ensure timely and accurate execution of labeling requirements.
- Ensure compliance with regulatory standards related to medical device manufacturing and labeling.
- Identify process improvements to enhance operational efficiency and compliance.
Required Qualifications:
- Proven experience in labeling processes within the medical device industry.
- Strong knowledge of medical device manufacturing and regulatory requirements.
- Experience working with labeling systems such as LMD (Labeling Management Database).
- Excellent stakeholder management and communication skills.
- Strong attention to detail and organizational abilities.
Preferred Qualifications:
- Experience supporting global trade or international operations.
- Familiarity with FDA and international regulatory guidelines.
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Katalyst Healthcares & Life Sciences