Product Management

4 days ago

Kamunting, Perak, Malaysia Onetexx Sdn. Bhd. Full time

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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