QA/RA Expert

Key Responsibilities:

1. Regulatory Affairs & Global Compliance

Ensure compliance with applicable regulatory and quality requirements for medical protective gloves

Prepare, review, and maintain regulatory documentation for global market access (MDR, PPE, ISO, FDA where applicable)

Preparing and maintaining technical documentation according to MDR, PPE Regulation, and ISO requirements

Collect, review, and organize evidence for conformity assessment of products

Prepare documentation for submissions to Notified Bodies/ Authorities, checklists, gap analyses, and regulatory reports

Submit applications and communicate with the Notified bodies and Local Authorities

Stay updated with local, EU (MDR & PPE), and FDA regulations and best practices related to medical devices and personal protective equipment

Participate in courses and seminars related to EU regulations and Medical Device updates

Manage product-related documentation, approvals, certifications, and compliance workflows

Maintain documentation accuracy and regulatory traceability

2. Quality Management System (QMS) & Compliance

Ensure continuous maintenance, alignment, and improvement of the company's Quality Management System

Support internal quality processes, documentation control, audits, and continuous improvement initiatives

Prepare QMS deliverables for MDR, PPE, and ISO compliance

Execute internal audit preparation, CAPA follow-up, risk documentation updates, and quality records management

Handle product complaints, evaluate customer feedback, and coordinate necessary follow-up actions

Participate in risk assessments, change control activities, and product lifecycle documentation

Ensure compliance with the Company's Management System and Policies

Coordinate follow-up actions for complaints, non-conformities, and quality events

Perform on-site or online quality inspections, batch-level checks, and pre-shipment verification of examination gloves at manufacturing facilities

Conduct inspections primarily within Malaysia and other Asian countries, as required

Evaluate supplier quality performance and assist in supplier evaluation processes

Address and discuss quality issues and corrective actions with superiors and manufacturing stakeholders

Ensure standards and safety regulations are observed at manufacturing sites

3. Stakeholder Collaboration & Operational Support

Liaise with internal teams and external stakeholders to ensure regulatory readiness and operational compliance

Assist in organizing and implementing training sessions related to QMS and regulatory requirements

Collaborate across multicultural teams in an international operational environment

Qualifications:

Bachelor's degree in Life Sciences, Biomedical Sciences, Chemistry, Engineering, or other relevant scientific discipline

Minimum of 1 year of solid professional experience in Regulatory Affairs or Quality Management within the examination/surgical gloves sector

Strong background in Quality Management and Regulatory Affairs within medical products

Demonstrated experience in product documentation, approvals, certifications, and regulatory compliance workflows

Strong understanding of European and international regulatory requirements applicable to medical products

Ability to work independently, take ownership of assigned responsibilities, and achieve operational autonomy

Willingness and flexibility to travel internationally to manufacturing sites, primarily within Malaysia and other Asian countries, as required

Excellent analytical, organizational, and problem-solving skills

Strong communication skills with the ability to collaborate effectively across multicultural teams

High level of integrity, accountability, and attention to detail

Excellent written and spoken English