Senior Executive - Regulatory Affairs (Medical device)

Hartalega; Sepang; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Hartalega in Malaysia is seeking a Regulatory Affairs professional to oversee submissions, licensing, and compliance for medical device products. You will coordinate global registrations and monitor regulatory changes to ensure readiness for audits and inspections.

The role requires a Bachelor’s degree and at least 4 years of manufacturing experience, with regulatory knowledge considered an added advantage. You will work with R&D, QA, Manufacturing, and Sales to keep compliant processes.

Formación

• Bachelor’s degree in science/engineering or related field.
• Minimum of 4 years of working experience in manufacturing environment.
• Medical device regulatory knowledge is an added advantage.

Responsabilidades

• Prepare, compile, and maintain regulatory submissions for new products, renewals, listings, and certifications.
• Manage product licensing, technical files, PMS, PMCF, clinical evaluations, and other regulatory documentation.
• Track and communicate global regulatory changes and updates.
• Document and review regulatory-related design and development activities for compliance.
• Liaise with regulatory authorities, agents, and notified bodies for inquiries and inspections.
• Monitor and respond to adverse events, import alerts, and regulatory inquiries.
• Oversee audits and inspections by preparing documentation and coordinating logistics.
• Compile regulatory data and provide input for new product development and internal reporting.
• Collaborate with cross-functional teams to align regulatory activities and stakeholders.

Descripción del empleo

• Oversee that company operations and products comply with regulatory and statutory requirements. It involves preparing, submitting, and maintaining product registrations and licenses while adhering to international regulations and standards. Monitors compliance to support regulatory readiness and operational integrity.

Job Responsibilities

• Prepare, compile, and maintain regulatory submissions for new products, renewals, listings, and certifications (e.g., 510(k), CE Mark, STED, Design Dossiers, international submissions).
• Manage product licensing, technical files, PMS, PMCF, clinical evaluations, and other regulatory documentation to maintain legal compliance and regulatory readiness.
• Track and communicate global regulatory changes and updates to ensure company practices remain aligned with evolving requirements.
• Document and review regulatory-related design and development activities, ensuring compliance of materials, testing, and validations.
• Liaise with regulatory authorities, designated agents, and notified bodies for routine inquiries, submissions, and inspections.
• Monitor and respond to adverse events, import alerts, and customer regulatory inquiries, escalating complex issues as needed.
• Oversee the audits and inspections by preparing documentation, coordinating logistics, and ensuring staff readiness.
• Compile regulatory data and provide input for new product development, NPD/NI projects, and internal reporting to senior management.
• Collaborate with cross-functional teams (R&D, QA, Manufacturing, Sales, Marketing) to align regulatory activities and maintain professional stakeholder relationships.
• Train and guide new and existing regulatory staff while contributing to continuous improvement of regulatory processes.

Job Requirements

• Bachelor’s Degree in Science / Engineering or any related field.
• Minimum of 4 years of working experience in manufacturing environment.
• Medical device regulatory knowledge will be an added advantage