Regulatory Affairs Associate

NCS Solutions

Bayan Lepas

On-site

MYR 78,000 - 112,000

Full time

6 days ago

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Benefits offered by this job

Annual Leave

Medical and Hospitalisation Leave

EPF

SOCSO

EIS

Performance Bonus

Annual Bonus

Training Provided

Job summary

NCS Solutions is seeking a detail‑oriented Regulatory Specialist I to support global regulatory compliance for a portfolio of technology products across international markets.

You will work with Engineering, manufacturing partners, test labs, certification agencies, and internal teams to ensure certifications remain current, manage renewals, coordinate sample shipments, and maintain comprehensive regulatory records throughout the product lifecycle.

Qualifications

Bachelor's Degree or equivalent experience preferred.
1 - 3 years of working experience in document control, compliance, quality, regulatory affairs, or project coordination is an advantage.
Strong English communication and coordination skills when working with internal and external stakeholders.
Proficiency in Mandarin to support Taiwan customers/members.
Experience with ERP systems (Oracle or similar) is an advantage.
Basic knowledge of SQL databases is preferred but not required.

Responsibilities

Regulatory certification support for global markets and products.
Coordinate procurement, tracking, and delivery of product samples for testing and certifications.
Maintain regulatory documentation libraries and technical files across platforms.
Handle regulatory document requests and provide certificates, reports, and declarations as needed.
Collaborate with engineering, manufacturing, testing labs, and regulatory bodies worldwide.

Skills

Strong English communication

Mandarin proficiency

Documentation coordination

Attention to detail

Education

Bachelor's Degree

Tools

ERP systems (Oracle)

SQL databases

Job description

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Bachelor's Degree or equivalent experience preferred.

1 - 3 years of working experience in document control, compliance, quality, regulatory affairs, or project coordination is an advantage.

Strong English communication and coordination skills when working with internal and external stakeholders.

Proficiency in Mandarin to support Taiwan customers/members.

Experience with ERP systems (Oracle or similar) is an advantage.

Basic knowledge of SQL databases is preferred but not required.

Comfortable handling large volumes of documentation and detailed record management.

Strong organizational skills with the ability to manage multiple tasks and deadlines simultaneously.

Excellent attention to detail and documentation management capabilities.

Ability to work independently while collaborating effectively within a global team environment.

Requirement

Key Qualifications & Skills

Bachelor's Degree or equivalent experience preferred.
1 - 3 years of working experience in document control, compliance, quality, regulatory affairs, or project coordination is an advantage.
Strong English communication and coordination skills when working with internal and external stakeholders.
Proficiency in Mandarin to support Taiwan customers/members.
Experience with ERP systems (Oracle or similar) is an advantage.
Basic knowledge of SQL databases is preferred but not required.
Comfortable handling large volumes of documentation and detailed record management.
Strong organizational skills with the ability to manage multiple tasks and deadlines simultaneously.
Excellent attention to detail and documentation management capabilities.
Ability to work independently while collaborating effectively within a global team environment.

Responsibility

Job Summary

We are seeking a detail-oriented and organized Regulatory Specialist I to support global regulatory compliance activities for a portfolio of technology products sold across multiple international markets.

As part of the Enterprise Visibility and Mobility (EVM) Regulatory department, you will work closely with Engineering teams, manufacturing partners, test laboratories, certification agencies, and internal stakeholders to ensure regulatory certifications remain current and compliant throughout the product lifecycle. You will play a key role in managing certification renewals, coordinating product samples for testing, maintaining regulatory documentation, and supporting requests for compliance-related information from global authorities and customers.

Essential Duties and Responsibilities:

1. Regulatory Certification Support

Support regulatory certification and compliance activities for new and existing products across global markets.
Monitor certification renewal schedules and compliance requirements to ensure certifications remain current.
Maintain and update regulatory certification records and document repositories.
Assist with continued compliance activities and certification renewal projects.

2. Sample Procurement & Test Coordination

Coordinate procurement, ordering, tracking, and delivery of product samples required for certification renewals and compliance testing.
Work closely with internal teams and order management functions to ensure timely sample fulfillment.
Follow up on shipment status and proactively resolve delays to prevent impacts on certification schedules.
Coordinate sample modification activities when required to support testing and certification requirements.
Provide shipment and tracking information to internal stakeholders, testing laboratories, and external partners.

3. Documentation & Regulatory Records Management

Maintain regulatory documentation libraries, technical files, and certification records across various document management platforms.
Support the organization and maintenance of Technical Construction Files (TCF) and other compliance-related documentation.
Learn and navigate regulatory document repositories, network drives, SharePoint sites, databases, and document management systems.
Assist in publishing and maintaining regulatory certificates on company websites and internal systems.

4. Document Request Management

Act as the first point of contact for regulatory document requests from internal and external stakeholders.
Coordinate the retrieval and provision of certificates, test reports, declarations, technical documents, and other compliance-related records.
Research and locate supporting documentation from regulatory libraries and technical files.
Work with subject matter experts to obtain documentation when requests require additional investigation or clarification.
Support evolving regulatory requirements where certification agencies and authorities may request customized documentation beyond standard certificates.

5. Cross-Functional Collaboration

Collaborate with Engineering teams, manufacturing partners, test laboratories, certification bodies, and regulatory agencies worldwide.
Provide regulatory documentation and information to external partners upon request.
Support new product introduction (NPI) activities and sustaining compliance programs.
Assist with customs-related documentation and regulatory processes as required.

Benefits