Regulatory Executive

Fulijaya Manufacturing; Kulim; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading manufacturing company in Kulim is seeking a Regulatory Executive to ensure compliance with laws and industry standards. The role involves managing ISO 9001 compliance, leading improvement projects, and upholding safety standards. Ideal candidates will have relevant degrees and experience in regulatory affairs, along with strong communication and problem-solving skills.

Qualifications

• Minimum 2-3 years experience in Regulatory & Compliance or Quality Assurance.
• Certified Halal Executive; Appointed QMS, EMS Internal Auditor.

Responsibilities

• Ensure ISO 9001 QMS compliance and drive continuous improvement.
• Manage ongoing improvement projects related to GMP and other standards.
• Collaborate to enhance internal capabilities and external reputation.

Skills

Effective communication

Problem-solving

Analytical skills

Self-management

Education

Degree or diploma in Quality Management

Regulatory Affairs

Science

Engineering

Tools

Microsoft Office Suite

BI

SAP

Job description

The Regulatory Executive is responsible for ensuring the Organisation's adherence to all relevant laws, regulations, and industry standards. This includes proactively monitoring changes, interpreting their impact, and developing/implementing necessary actions and policies to maintain full compliance.

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Ensuring ISO 9001 QMS Compliance: Maintaining adherence to ISO 9001 standards and systems, driving continuous improvement through corrective and preventive actions, ensuring quality objectives align with policies, and communicating QMS processes effectively across departments. This includes establishing and managing the annual internal audit program and developing internal auditor competency.
2. Managing Standards and Capability Improvement Projects: Leading and managing ongoing improvement projects related to GMP, US FDA, Halal, ISO 22716, SEDEX, ESG, and other relevant standards.
3. Driving Standards Upgrades: Collaborating with HR and Sales & Marketing to enhance the Organisation's internal capabilities and external reputation through the adoption of upgraded industry standards such as ISO certifications and FDA requirements.
4. Managing Registrations and Renewals: Maintaining and renewing the Organisation's and Home Brand's trademarks, GS1 Barcode registrations, and other relevant registrations.
5. Upholding Safety Standards: Ensuring personal safety, the safety of colleagues, and Organisation property, and adhering to occupational safety and health policies.
6. Undertaking Additional Tasks: Handling other projects and assignments as required.

JOB REQUIREMENTS:

• Degree or diploma in a relevant specialization (e.g., Quality Management, Regulatory Affairs, Science, Engineering).
• Years of Experience: A minimum of 2-3 years of working experience in Regulatory & Compliance and/or Quality Assurance/Quality Control is preferred.
• Professional Certificates/Licenses: Certified Halal Executive; Appointed QMS, EMS Internal Auditor.

Essential Skills and Competencies:

• Effective communication skills in English and Bahasa Malaysia, both verbal and written.
• Practical understanding of ISO 9001:2015 and ISO 14001:2015 standards.
• Experience with ISO 22716:2007 and ISO 13485:2016 is advantageous.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and relevant applications like BI and SAP.
• Strong self-management skills, meticulous attention to detail, and the ability to meet demanding deadlines.
• Excellent problem-solving and analytical skills, with a proactive, collaborative approach.