Regulatory Affairs Executive

UMMI Surgical; Shah Alam; On-site; MYR 67,000 - 109,000; Full time

Job summary

UMMI Surgical Sdn Bhd in Malaysia is seeking a Regulatory Affairs professional to manage medical device registrations and ensure MDA GDPMD compliance across the product lifecycle.

You will maintain the QMS, prepare regulatory submissions, coordinate approvals, and liaise with external authorities to support timely audits and certification activities, helping deliver compliant devices to healthcare providers nationwide.

Qualifications

• 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.
• Proficient in Microsoft Office applications (Word, Excel, and PowerPoint).
• Proficient in English and Bahasa Malaysia (written and spoken).
• Detail-oriented, organised and able to manage multiple tasks.
• Positive attitude with good interpersonal and teamwork skills.

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.

Skills

Regulatory affairs

Attention to detail

Organised

English proficiency

Bahasa Malaysia

Interpersonal skills

Teamwork

Documentation

Education

Bachelor's degree in Life Sciences / Biology / Chemistry / Biomedical Science

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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.

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