Lyra Mae Bedia

Dynamic quality management professional with extensive experience in ensuring compliance with ISO standards, especially the medical device sector. Proven track record in promoting and implementing EU regulation and ISO quality management systems, conducting thorough internal audits, and facilitating successful external audits. Expertise in managing comprehensive documentation related to quality management systems, driving continuous improvement initiatives, and fostering a culture of quality across organizations.

Committed to enhancing operational efficiency and maintaining the highest standards of regulatory compliance.

Regulatory Officer at International Organization for Standardization (2022-06 – Present)

• Documentation Management: Develop, Implement, review, and update Quality Management System's (QMS) documented information based on ISO 9001:2015 & 13485:2016, MDSAP and EU regulations across the organization.
• Audit Management: Lead internal audits and certification audit. Prepare audit summary and reports, Conduct root-cause analysis, and coordinate with external certification bodies for product registrations and.
• Compliance Monitoring: Ensure organizational activities align with ISO standards, legal and regulatory requirements.
• Complaint Handling: Investigate customer complaints and resolves root cause of problems identified. Perform the necessary countermeasure to the nonconformities with the aim of preventing recurrence.
• Risk Management: Identify organizational hazards and manage risk assessment, particularly for Risk Management to Medical Devices (ISO 14971).
• HR and Administrative Support: Organize company-wide training, orientations, and campaigns to foster a culture of compliance and quality, while also supporting HR and Administrative tasks such as managing calendars, scheduling and meeting coordination. Maintaining paper and digital files, updating databases and drafting emails

Position not specified at Impex Staff (Import & Export) (2022-09 – 2022-12)

• Paperwork: Prepare commercial / International invoices, packing lists, import/export declarations, and customs entries.
• Coordination: Work with freight forwarders, customs brokers, suppliers, and shipping lines for smooth pickup and delivery.
• Compliance: Process permits and clearances through local agencies like the Bureau of Customs (BOC) and PEZA.
• Tracking: Monitor real-time shipment statuses and compute estimated duties, taxes, or shipping costs.
• Record Keeping: Maintain updated ledgers, inventory reports, and shipping logs.

Document Control Clerk (DCC) at Position not specified (2021-03 – 2022-06)

• Document Management & Accuracy: Managing version control of documents & execute scanning, uploading, indexing, and filing of both electronic and physical documents and records.
• Quality Control & Compliance: Reviewing documents for accuracy, ensuring compliance with ISO and company standards, and maintaining master document lists.
• Distribution & Access: Managing the flow of documents to relevant stakeholders, keeping personnel updated on new document versions, and managing access permissions.
• Records Retention: Establishing retention schedules and securely archiving or disposing of outdated documents.

Bachelor of Business Administration in Financial Management (Cum Laude)– Palawan State University - Cuyo Campus (2015 – 2019) High School Graduate – Tanza National Comprehensive High School (2010 – 2014)