What Global Trade International Logistics & Operations contributes to Cardinal Health
 
Global Trade is responsible for the design, implementation and execution of policies, programs and platforms to enable compliant and efficient international movement of products and technologies.
 
Global Trade International Logistics & Operations is responsible for managing Global Trade execution focused on compliance, delivery excellence and cost optimization. This job family implements and executes Global Trade policies and serves as primary interface to internal business operations, as well as forwarders, carriers, shippers and customs house brokers. 

We are seeking an experienced Import Operations FDA Specialist/Advisor with expertise in FDA compliance for medical devices import. The ideal candidate will have a strong background in international freight forwarding and customs brokerage operations, coupled with a thorough understanding of FDA requirements for importing medical devices. This role involves managing import operations, ensuring FDA compliance, and collaborating with internal teams and customs brokers to streamline processes and resolve issues effectively.

Responsibilities

Oversee import operations for medical devices (but not limited to) pertaining to FDA, including coordination with freight forwarders and customs brokers to ensure timely clearance.

Ensure compliance with FDA regulations for imported medical devices, including affirmation of compliance requirements and documentation.

Generate reports on shipments under FDA hold status and FDA inquiries from customs broker before entry submission, track clearance progress, and coordinate with internal teams to address any issues.

Work closely with customs brokers to provide accurate FDA-related information and respond to FDA requests promptly.

Collaborate with internal teams to maintain and clean up the import database, ensuring accuracy and completeness of records.

Develop and maintain strong relationships with customs brokers and other stakeholders to facilitate smooth FDA clearance on import shipments.

Provide guidance and support to internal teams on FDA compliance requirements and import procedures.

Monitor changes in FDA regulations and update import processes accordingly to ensure compliance.

Create and document detailed work instructions for daily operations in this role.

Experience with South border crossing operations is a plus, with the ability to navigate additional regulatory and operational requirements.

Assist in the resolution of import-related issues, including customs and FDA delays, documentation discrepancies, and FDA inquiries.

Qualifications

Bachelor's degree in Supply Chain Management, International Business, or a related field.

4-8 years of experience in import operations, preferably in the international trade industry related to FDA.

English: Advance (speak, read, write).

Strong understanding of freight forwarding and customs brokerage processes, with the ability to navigate complex import procedures.

In-depth knowledge of FDA regulations pertaining to medical devices, including affirmation of compliance requirements.

Experience creating and managing reports, tracking FDA hold statuses, and resolving clearance issues.

Ability to work collaboratively with internal teams and external partners to achieve import objectives.

Excellent communication and interpersonal skills, with the ability to effectively liaise with customs brokers, FDA officials, and internal stakeholders.

Familiarity with import databases and systems, with the ability to clean up and maintain import records.

Proactive approach to problem-solving and ability to work under pressure in a fast-paced environment.

Experience with South border crossing operations and additional regulatory knowledge is advantageous.

What is expected of you and others at this level

Participates in the development of policies and procedures to achieve specific goalsEnsures employees operate within guidelinesDecisions have a short-term impact on work processes, outcomes and customersInteracts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior managementInteractions normally involve resolution of issues related to operations and/or projectsGains consensus from various parties involved

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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