- Selama, Perak Selama Perak Malaysia
Working Location
Job Description
Responsibilities
Product Management & Regulatory Support
Conduct market research to identify customer needs and product improvement opportunities.
Ensure products and packaging comply with quality, safety, and regulatory standards.
Review and summarize regulatory requirements for gloves.
Prepare and maintain regulatory documentation, technical files, and submissions (including 510(k)).
Liaise with regulatory agencies and update internal teams on regulation changes.
Review product labels, artwork, specifications, and promotional materials for compliance.
Customer Engagement & Support
Act as the main contact for customer enquiries, requirements, and sample discussions.
Manage customer information in CRM and share updated product documents.
Follow up on sample feedback and clarify any specification issues.
Prepare quotations and Proforma Invoices based on confirmed requirements.
Order Coordination & Product Realisation
Coordinate artwork review between customers, PM, and RA teams.
Initiate Customer Product Specification Sheet (CPS) and arrange packaging material procurement.
Lead Product Launching Meetings to align production, packaging, and quality teams.
Provide customers with delivery timelines, shipment updates, and relevant documents.
Payment & Shipment Oversight
Track and remind teams of pending payments before shipment release.
Support logistics by coordinating commercial invoices, packing lists, and shipment arrangements.
Share final inspection reports and oversee container loading when required.
Complaint Management
Receive and categorise complaints, gather evidence, and coordinate investigation.
Act as customer liaison until resolution and closure.
Skills & Competencies
Product management & regulatory knowledge
Strong communication and interpersonal skills
Documentation and analytical skills
Cross-functional coordination
Organized, systematic, and detail-oriented
Education & Experience
Any bachelor’s degree.
Minimum 2 years’ experience in a medical regulatory affair.
Familiarity with medical device regulations, glove manufacturing processes, quality assurance, and regulatory requirements across different countries.
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