Senior Executive, Regulatory Affairs

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

About us

Comfort Rubber Gloves Industries Sdn Bhd is a leading manufacturer in the rubber gloves industry, committed to delivering high-quality protective products that meet international standards. We specialise in producing reliable and innovative rubber gloves for healthcare, industrial, and consumer markets. Our company is dedicated to maintaining excellence in manufacturing, quality assurance, and regulatory compliance whilst fostering a culture of continuous improvement and employee development.

About the role

We are seeking a Senior Executive, Regulatory Affairs to join our Quality Assurance & Control team in Taiping, Perak. This is a full-time position that plays a crucial strategic role in ensuring our products meet all regulatory requirements across local and international markets. You will be responsible for managing regulatory compliance, liaising with regulatory bodies, and ensuring that our manufacturing operations adhere to the highest standards of quality and safety. This role is integral to protecting our company's reputation and facilitating market access for our products globally.

Key responsibilities

• Develop and maintain comprehensive regulatory strategies and policies to ensure compliance with local and international regulations governing rubber glove manufacturing and distribution
• Manage submissions and communications with regulatory authorities, including applications for product approvals, certifications, and licence renewals
• Conduct regulatory impact assessments for new products and manufacturing processes, identifying potential compliance risks and recommending mitigation strategies
• Lead the preparation and maintenance of regulatory documentation, including technical files, quality dossiers, and product safety data
• Monitor changes in regulatory requirements and industry standards, ensuring the organisation remains updated and compliant with evolving legislation
• Collaborate with manufacturing, quality assurance, and product development teams to ensure regulatory considerations are integrated into operational processes
• Conduct internal audits and inspections to verify compliance with regulatory requirements and company policies
• Represent the organisation in meetings and communications with regulatory bodies, inspectorates, and industry associations
• Ensure that the planning of the Quality Management System is carried out to meet the requirements of ISO 9001 , ISO 13485 and the Quality Objectives.
• Maintain detailed records of all regulatory activities, certifications, and correspondence for audit and traceability purposes

What we're looking for

• Bachelor's degree in 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 beneficialMeticulous 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

What we offer

Comfort Rubber Gloves Industries Sdn Bhd is committed to providing a supportive and rewarding work environment. We offer competitive remuneration packages commensurate with experience and qualifications. Our benefits include comprehensive health and wellness programmes, opportunities for professional development and training, career advancement pathways, and a collaborative workplace culture that values innovation and excellence. We recognise the importance of work-life balance and strive to create flexible working arrangements where possible. Additionally, we provide access to industry conferences and certifications to support your professional growth within the regulatory affairs field.

• Medical Miscellaneous allowance
• Parking
• Employee Training & Development
• Medical Insurance

Company Information

Comfort Rubber Gloves Industries Sdn Bhd - subsidiary of Comfort Gloves Berhad (formerly known as Integrated Rubber Corporation Berhad) which is listed on the main board of Malaysia's Stock Exchange BMSB (Bursa Malaysia Securities Berhad), a leading latex examination gloves manufacturer located in Taiping, Perak Darul Ridzuan.

Comfort Rubber Gloves Industries Sdn Bhd - subsidiary of Comfort Gloves Berhad (formerly known as Integrated Rubber Corporation Berhad) which is listed on the main board of Malaysia's Stock Exchange BMSB (Bursa Malaysia Securities Berhad), a leading latex examination gloves manufacturer located in Taiping, Perak Darul Ridzuan.