Regulatory Affairs Executive

Overview

Regulatory Affairs Executive Jobs in Shah Alam, Selangor, Malaysia at UMMI Surgical Sdn Bhd

Title: Regulatory Affairs Executive

Company: UMMI Surgical Sdn Bhd

Location: Shah Alam, Selangor, Malaysia

Do you have strong attention to detail and an interest in regulatory compliance? Join UMMI Surgical Sdn Bhd, a trusted provider of medical devices and healthcare solutions.

In this role, you will be responsible for managing product registrations, ensuring compliance with Medical Device Authority (MDA) requirements, and maintaining the Quality Management System (QMS) in accordance with GDPMD standards. You will play an important role in supporting the delivery of compliant and high-quality medical devices to healthcare providers throughout Malaysia.

Key Responsibilities

1. Handle medical device product registrations, renewals, and change notifications with the Medical Device Authority (MDA).
2. Apply for, maintain, and renew the company's Establishment Licence and other regulatory approvals.
3. Prepare and submit regulatory applications and follow up closely on authority queries through to approval.
4. Develop, review, and maintain Quality Manuals, SOPs, forms and related quality documentation.
5. Ensure the Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with GDPMD requirements.
6. Coordinate and monitor QMS activities, including document control, corrective and preventive actions (CAPA), and continuous improvement initiatives.
7. Liaise with external parties on regulatory and quality-related matters.
8. Support internal and external audits, inspections, and certification activities and ensure timely follow-up on audit findings.
9. Work closely with internal departments to ensure compliance with regulatory, quality, and company requirements.
10. Promote awareness of regulatory and quality requirements throughout the organisation.
11. Maintain accurate regulatory records, licences, registrations and quality documentation.

Qualifications & Requirements

• Degree in Life Sciences, Biology, Chemistry, Biomedical Science or related field
• Experience in Regulatory Affairs, GDPMD or the medical device industry will have an added advantage
• Good knowledge of MDA regulations, GDPMD requirements and medical device registration processes is preferred
• Proficient in Microsoft Office applications (Word, Excel, and PowerPoint)
• Proficient in in English and Bahasa Malaysia (written and spoken)
• Responsible, detail-oriented, organised and able to manage multiple tasks effectively
• Positive attitude with good interpersonal and teamwork skills