Senior Regulatory Affairs Lead - Global Compliance & QA

Comfort Rubber Gloves Industries Sdn Bhd; Taiping; On-site; MYR 100,000 - 145,000; Full time

Benefits offered by this job

Medical Miscellaneous allowance

Parking

Employee Training & Development

Medical Insurance

Job summary

Comfort Rubber Gloves Industries Sdn Bhd is seeking a Senior Executive, Regulatory Affairs to join our Quality Assurance & Control team in Taiping, Perak. This role manages regulatory compliance across local and international markets, coordinating with authorities and ensuring manufacturing operations meet high standards of quality and safety.

You will lead documentation, monitor regulatory changes, and collaborate with manufacturing and product development to embed regulatory requirements into

Qualifications

• Bachelor's degree in a related field; additional qualifications in regulatory affairs or quality management are highly desirable.
• Minimum of 3 years' professional experience in regulatory affairs, quality assurance, or compliance, preferably within the rubber manufacturing or medical device industries.
• Strong knowledge of international regulatory frameworks, including FDA, CE marking, ISO standards, and Malaysian regulatory requirements.
• Proven experience in preparing and submitting regulatory documentation and managing the approval process with regulatory authorities.
• Excellent understanding of quality management systems (ISO 9001, ISO 13485) and manufacturing compliance standards.
• Demonstrated ability to interpret complex regulatory documents and communicate compliance requirements to cross-functional teams.
• Strong project management skills with the ability to manage multiple regulatory initiatives simultaneously.
• Excellent written and verbal communication skills in English; knowledge of other languages is an advantage.
• Proficiency with regulatory software and databases; experience with quality management information systems is beneficial.
• Meticulous attention to detail with strong organizational and analytical capabilities.
• Ability to work independently and collaboratively within a team environment, with strong leadership and mentoring capabilities.

Responsibilities

• Develop regulatory strategies and policies to ensure compliance with local and international regulations for rubber glove manufacturing and distribution.
• Manage submissions and communications with regulatory authorities, including product approvals, certifications, and licence renewals.
• Conduct regulatory impact assessments for new products and manufacturing processes, identifying risks and mitigation strategies.
• Lead preparation and maintenance of regulatory documentation, including technical files, quality dossiers, and product safety data.
• Monitor changes in regulatory requirements and industry standards to keep the organisation compliant.
• Collaborate with manufacturing, quality assurance, and product development to integrate regulatory considerations into operations.
• Conduct internal audits and inspections to verify regulatory compliance and company policies.
• Represent the organisation in meetings with regulatory bodies, inspectorates, and industry associations.
• Ensure planning of the Quality Management System meets ISO 9001, ISO 13485 and quality objectives.
• Maintain detailed records of regulatory activities, certifications, and correspondence for audits.

Skills

Regulatory affairs

Quality assurance

Project management

Communication skills

Leadership & mentoring

Regulatory software

Cross-functional collaboration

Education

Bachelor's degree

Regulatory affairs qualification

Quality management qualification

Tools

ISO 9001

ISO 13485

Regulatory software

Job description

Comfort Rubber Gloves Industries Sdn Bhd is seeking a Senior Executive, Regulatory Affairs to join our Quality Assurance & Control team in Taiping, Perak. This role manages regulatory compliance across local and international markets, coordinating with authorities and ensuring manufacturing operations meet high standards of quality and safety.

You will lead documentation, monitor regulatory changes, and collaborate with manufacturing and product development to embed regulatory requirements into