Assistant Manager – Regulatory Affairs

Koon Seng Sdn Bhd; Johor; On-site; MYR 90,000 - 150,000; Full time

Job summary

Koon Seng Sdn Bhd, a leading glove manufacturer in Malaysia, seeks an experienced Assistant Manager – Regulatory Affairs to oversee regulatory activities for medical glove products in international markets. You will ensure compliance, manage registrations, documentation, and coordination with authorities, customers, and internal teams.

The role requires a Bachelor’s in a science/engineering field and at least 5 years RA experience in medical devices, with knowledge of US FDA, EU MDR, ISO 13485,

Qualifications

• Bachelor's Degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering, or related field.
• Minimum 5 years of hands-on Regulatory Affairs experience in the medical device industry.
• Experience with international product registrations and regulatory submissions preferred.
• Knowledge of US FDA medical device requirements and 510(k) submissions, EU MDR, CE marking, ISO 13485, Health Canada, MDA.
• Strong regulatory writing, analytical, and documentation control skills.
• Excellent attention to detail and ability to manage multiple registrations and deadlines.
• Proficient in English and Bahasa Malaysia.

Responsibilities

• Ensure products comply with regulatory requirements in relevant markets.
• Support new product development and changes with regulatory input.
• Prepare and maintain technical documentation and filings.
• Monitor regulatory changes and assess impact on company.
• Coordinate submissions, registrations, renewals, and certifications.
• Support inspections and audits by authorities and notified bodies.
• Collaborate with QA, R&D, Production, Sales, and Purchasing on regulatory matters.
• Review product artwork, labeling and IFU for compliance.
• Maintain regulatory intelligence and post-market information.

Skills

Regulatory affairs

Regulatory writing

Analytical skills

Documentation control

Project management

English proficiency

Bahasa Malaysia

Education

Bachelor's Degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering

Job description

We are seeking an experienced and detail-oriented Assistant Manager – Regulatory Affairs to support and manage regulatory activities for our medical glove products across international markets. The successful candidate will be responsible for ensuring that our products and manufacturing operations comply with applicable regulatory requirements and standards. The role includes product registrations and renewals, regulatory submissions, maintenance of technical documentation, regulatory intelligence, labelling review, audit/inspection support, and coordination with regulatory authorities, designated representatives, customers, and internal departments.

Key responsibilities

Ensure that manufactured and distributed products comply with applicable regulatory and statutory requirements in relevant markets

Provide regulatory support for new product development, product changes, and currently marketed products

Review and revise regulatory-related SOPs, procedures, and work instructions when required

Monitor changes in regulatory legislation, standards, guidance documents, and industry requirements and assess their impact on the company and its products

Manage and coordinate regulatory submissions, product registrations, renewals, listings, notifications, and certifications for local and international markets

Prepare, review, maintain, and update Technical Documentation / Technical Files in accordance with applicable regulatory requirements

Review new and revised product artwork, packaging, labelling, Instructions for Use (IFU), and product claims to ensure compliance with applicable regulatory requirements

Monitor and review adverse events, complaints, recalls, safety notices, FDA import alerts, regulatory enforcement actions, and other relevant post-market information

Support and coordinate regulatory inspections and audits by regulatory authorities, notified bodies, certification bodies, customers, and other external organisations

Work closely with QA, R&D, Production, Sales & Marketing, Purchasing, and other departments on regulatory matters

About you

Bachelor's Degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering, or another relevant discipline

Minimum 5 years of hands‑on Regulatory Affairs experience, preferably in the medical device industry

Experience in medical glove, rubber, polymer, healthcare, or related manufacturing industries will be an advantage

Candidates with experience handling international product registrations and regulatory submissions will be strongly preferred

Good working knowledge of one or more of the following: US FDA medical device requirements and 510(k) submissions, EU Medical Device Regulation (EU MDR), CE marking and Technical Documentation, ISO 13485 Quality Management System, Health Canada Medical Device Licensing, Malaysia Medical Device Authority (MDA) requirements

Strong technical and regulatory writing skills

Good analytical and problem‑solving abilities

Excellent attention to detail and documentation control

Strong organisational and time-management skills with the ability to manage multiple registrations, renewals, and deadlines simultaneously

Good command of English and Bahasa Malaysia, both written and spoken

Located in the Southern Region of Malaysia.Koon Seng Sdn Bhd is one of the leading manufacturers of high quality non-sterile Latex and Nitrile Examination Gloves in Malaysia.

The company is highly committed to the manufacturing of high quality Latex and Nitrile Examination Gloves for the Medical and Industrial world markets. KSSB supporting by a team of dedicated and professional staff, KSSB strives to deliver the ultimate quality products at the best possible value to its customers.

At KSSB we realize that stringent quality control procedures in line with certified of ISO 9001, ISO 13485 & ISO 22000 and is well equipped and prepared to become one of leading quality manufacturers of Latex and Nitrile Examination Gloves in the World.

Located in the Southern Region of Malaysia.Koon Seng Sdn Bhd is one of the leading manufacturers of high quality non-sterile Latex and Nitrile Examination Gloves in Malaysia.

The company is highly committed to the manufacturing of high quality Latex and Nitrile Examination Gloves for the Medical and Industrial world markets. KSSB supporting by a team of dedicated and professional staff, KSSB strives to deliver the ultimate quality products at the best possible value to its customers.

At KSSB we realize that stringent quality control procedures in line with certified of ISO 9001, ISO 13485 & ISO 22000 and is well equipped and prepared to become one of leading quality manufacturers of Latex and Nitrile Examination Gloves in the World.