Senior Executive - Regulatory Affairs (Medical device)

Hartalega; Sepang; In loco; MYR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Hartalega in Malaysia seeks a Regulatory Affairs professional to oversee submissions, licensing, and regulatory documentation for products. You will collaborate with R&D, QA, Manufacturing, Sales to ensure compliance across regions.

The role involves tracking global regulatory changes, coordinating audits, and supporting continuous improvements in regulatory processes. A bachelor’s degree and 4+ years in manufacturing are required.

Competenze

• Bachelor’s Degree in Science / Engineering or related field.
• Minimum of 4 years of manufacturing experience.
• Medical device regulatory knowledge is a plus.

Mansioni

• Prepare and maintain regulatory submissions for new products and renewals.
• Manage licensing, technical files, PMS/PMCF, and regulatory documents.
• Track global regulatory changes and brief teams on impacts.
• Review regulatory aspects of design and development activities.
• Liaise with authorities, agents, and notified bodies for submissions.
• Monitor adverse events and regulatory inquiries; escalate as needed.
• Oversee audits and inspections; coordinate documentation.
• Provide regulatory data for new product development and reporting.
• Collaborate with R&D, QA, Manufacturing, Sales to align activities.
• Train regulatory staff and drive process improvements.

Formazione

Bachelor’s Degree in Science / Engineering or related field

Descrizione del lavoro

Job Purpose

• 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

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

Job Requirements

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