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.
