Associate Regulatory Affairs Systems Specialist

Medtronic plc; Taguig; On-site; PHP 500,000 - 700,000; Full time

Job summary

Medtronic plc busca un Associate Regulatory Affairs Systems Specialist en Taguig para coordinar actividades de presentación regulatoria y gestionar sistemas de cumplimiento. Colaborarás con equipos multifuncionales para asegurar entregables puntuales y documentación exacta en Southeast Asia.

El rol implica preparar paquetes de sumisión, mantener registros y coordinar certificados y documentos regulatorios. Se requiere licenciatura y experiencia previa mínima en regulación y operaciones

Qualifications

• Bachelor's degree with 1+ years of Regulatory Affairs or related field.
• Experience coordinating multiple projects and deadlines simultaneously.
• Proficient in Excel, Word, and PowerPoint; strong communication skills.

Responsibilities

• Coordinate regulatory submission activities, timelines, and deliverables across markets.
• Create, update, and maintain regulatory applications and records within systems.
• Prepare dossiers and submission packages for registrations and renewals.
• Track status and provide updates on projects.

Skills

Project coordination

Cross-functional collaboration

Regulatory documentation management

Written and verbal communication

Education

Bachelor's degree

Tools

Microsoft Excel

Microsoft Word

PowerPoint

RIM systems

Job description

## Associate Regulatory Affairs Systems SpecialistSolicitar: Acuerdo de trabajo flexible: Taguig City, National Capital Region, Philippines: Tiempo completo: Publicado hoy: R76731En Medtronic, puedes empezar una carrera para toda la vida que se centre en la investigación y en la innovación y que defienda la equidad y el acceso a la atención sanitaria para todos. Tu liderazgo dejará huella, eliminando obstáculos para impulsar la innovación en un mundo más conectado y humanitario.**Un día normal**The Regulatory Affairs function supports product registration, regulatory maintenance, and compliance activities across Southeast Asia. The team partners with Regulatory Affairs professionals, Operating Units, and cross-functional stakeholders to coordinate submissions, maintain regulatory documentation, and support market access activities that enable products to be commercialized and remain compliant with local regulatory requirements. The Associate Regulatory Affairs Systems Specialist supports regulatory operations through the management of regulatory systems, submission workflows, documentation tracking, and administrative processes. The role contributes to the timely execution of regulatory activities by ensuring data accuracy, process compliance, and effective coordination across multiple stakeholders. The Associate Regulatory Affairs Systems Specialist supports regulatory submission and registration activities across Southeast Asia by coordinating regulatory projects, maintaining regulatory systems, preparing submission documentation, tracking deliverables, and supporting compliance with country-specific regulatory requirements. This role collaborates with Regulatory Affairs teams, Operating Units, and cross-functional partners to help ensure timely and accurate regulatory submissions and product lifecycle maintenance activities.**Primary Responsibilities**: * Coordinate regulatory submission activities, timelines, and project deliverables across multiple Southeast Asia markets.* Create, update, and maintain regulatory applications, events, records, and tasks within regulatory systems.* Prepare, compile, and organize regulatory dossiers and submission packages for product registrations, renewals, and change submissions.* Track submission status and provide timely updates on regulatory projects and assigned activities.* Partner with Business Units and stakeholders to collect, verify, and maintain required regulatory documentation.* Request, manage, and track regulatory certificates and legal documents, including Certificates to Foreign Governments (CFGs), Free Sales Certificates (FSCs), and International Organization for Standardization (ISO) certificates.* Coordinate translation activities and ensure required submission materials are available and compliant with local requirements.* Support regulatory administrative activities and maintain accurate regulatory records and documentation. **Required Qualifications**: * Bachelor's degree with 1+ years of experience in Regulatory Affairs, Regulatory Operations, Healthcare, Medical Devices, Life Sciences, or a related regulated industry.* Experience managing documentation, records, or data within business systems.* Experience coordinating multiple projects, deliverables, and deadlines simultaneously.* Proficiency in Microsoft Excel, Word, and PowerPoint.* Written and verbal communication skills supporting cross-functional stakeholder collaboration. **Preferred Qualifications:** * Experience supporting medical device, pharmaceutical, biotechnology, or healthcare regulatory processes.* Knowledge of medical device registration, renewal, and product change submission requirements.* Experience with Regulatory Information Management (RIM) systems or document management platforms.* Experience preparing technical documentation, regulatory dossiers, or submission packages.* Experience supporting regional or multinational regulatory operations within Southeast Asia. Requisitos físicos del puestoLas declaraciones anteriores pretenden describir la naturaleza general y el nivel de trabajo que realizan los empleados asignados a este puesto, pero no son una lista exhaustiva de todas las responsabilidades y habilidades necesarias para este puesto.