Regulatory Affairs Executive

UMMI Surgical; Selangor; On-site; MYR 78,000 - 123,000; Full time

Benefits offered by this job

13th month salary

Medical insurance

Annual health screening

Job summary

UMMI Surgical Sdn Bhd in Shah Alam, Malaysia, seeks a Regulatory Affairs professional to manage medical device registrations and GDPMD/QMS compliance.

You will liaise with the Medical Device Authority, prepare submissions, maintain quality documentation, and support audits to ensure timely approvals.

The role requires attention to detail, English and Bahasa Malaysia proficiency, and a degree in life sciences or related field.

Qualifications

• Degree in Life Sciences, Biology, Chemistry, Biomedical Science or related field.
• Experience in Regulatory Affairs, GDPMD or the medical device industry is advantageous.
• Good knowledge of MDA regulations, GDPMD requirements and medical device registration processes.

Responsibilities

• Handle medical device registrations, renewals, and change notifications with the MDA.
• Apply for, maintain, and renew the Establishment Licence and other regulatory approvals.
• Submit regulatory applications and follow up on authority queries to approval.
• Develop, review, and maintain Quality Manuals, SOPs, forms and related documentation.
• Ensure the QMS is implemented, maintained and improved per GDPMD requirements.
• Coordinate and monitor QMS activities, including document control and CAPA.
• Liaise with external parties on regulatory and quality matters.
• Support internal and external audits, inspections, and certification activities.
• Collaborate with internal departments to ensure regulatory compliance.

Skills

Regulatory affairs

Attention to detail

Quality management systems

MS Office

Multitasking

Education

Bachelor's degree in Life Sciences/Biology/Biochemistry

Tools

QMS software

Job description

Location: HQ – Glenmarie, Shah Alam | Medical Device Industry

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

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

What We Offer

• Competitive salary package
• 13-month salary
• Medical, hospitalization & life insurance coverage
• Annual health screening, dental & optometry subsidy
• Continuous training and professional development
• Supportive and collaborative working environment

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 inin 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