Global Medical Device Logistics & Compliance Specialist

Align Technology, Inc.; Malaysia; On-site; MYR 60,000 - 120,000; Full time

Job summary

Align Technology, Inc. is seeking a Logistics Specialist in Malaysia to oversee OTC and SFDC inventory control, coordinate RMA returns, manage inbound/outbound asset movements, and ensure accurate invoicing from 3PL.

The role also handles freight performance, issue resolution with RCA/CAPA, and compliance with HS codes and export controls. You will navigate inbound/outbound processes for Class A/B medical devices in SEA, support global/regional rollouts, and maintain track-and-trace records with

Responsibilities

• Oversee SAP's Order-to-Cash (OTC) and SFDC (Salesforce) covering system inventory control and distribution management, completing daily tasks to ensure accuracy in inventory.
• Coordinate RMA return and coordination with local markets in order to achieve timely returns.
• Coordinate demo assets and sleeves inbound and outbound to designated sites and ensure the records of movement/flow are updated and traceable.
• Processing invoices from 3PL, including verifying accuracy of billing and ensuring AP processes payment on time.
• Monitor and manage freight and logistics partners' performance for shipping, customs clearance, warehousing and domestic distribution.
• Resolve shipping and distribution related issues (with internal and external logistics partners) and feedback with systematic Root Cause Analysis (RCA) and Corrective Actions - Preventive Actions (CAPA) Plan if the event of a Non-Conformance (NC).
• Enforce documentations used by both shipper for inbound and outbound are correct in terms of valuation, HS Code and COO among others.
• A grounded understanding of trade compliance and valuation and able to work with Trade Compliance and RA team on all customs matters involving HS Code, ECCN, import and export processes in certain countries.
• A basic understanding of export control regulations, a role as ECO will be an added advantage.
• Understand and able to navigate through inbound and outbound process for Class A and Class B medical device in SEA countries.
• Support and align with Global and Regional projects relating to Systems Roll-out, Go-To-Market Strategy, Regulatory Compliance, etc.
• Communicate all shipment issues to owners with resolutions.
• Assure and follow up on-time delivery of materials in the track and trace process.
• Responsible for ensuring adherence to documentation retention requirements with 3PLs and internal requirements and/or as specified within local regulations.
• Maintain relationships with business partners and vendors via MBR and QBR.
• Comply with all safety policies, practices and procedures including ISO13485 and GDPMD and other local country regulations.
• Perform other duties as assigned.

Job description

Align Technology, Inc. is seeking a Logistics Specialist in Malaysia to oversee OTC and SFDC inventory control, coordinate RMA returns, manage inbound/outbound asset movements, and ensure accurate invoicing from 3PL.

The role also handles freight performance, issue resolution with RCA/CAPA, and compliance with HS codes and export controls. You will navigate inbound/outbound processes for Class A/B medical devices in SEA, support global/regional rollouts, and maintain track-and-trace records with