Regulatory & Quality Associate

5 months ago


Johor Bahru, Malaysia ARQon Medtech Sdn. Bhd. Full time

**Roles and Responsibilities**

1.Support the senior engineers, quality, and regulatory compliance advisors in Medtech projects.

Project such as:

- Product technical documentation or technical file preparation on medical device such as engineering testing report, engineering product specifications, harmonised standards on the relevant medical device safety and performance as well as risk analysis related to product design, manufacturing, clinical & usability.
- Quality management system preparation and implementation for certification for medical device manufacturer and/or distributor such as design control procedures, manufacturing and quality process, statistics for sampling, and installation & distribution procedures
- Product registration with country dossier preparation from the product technical documentation & Quality Management system for Singapore HSA, CE, and global registration.

2. Support company administrative activities assigned to team related to medical device business.

3. Support on marketing, sourcing, and control management of resources (business, financial, human resource, facility)

4. Support in projects by understanding client needs, strategy planning, preparation of required documents or sourcing of information, tracking of status and communication to client for timely completion of projects.

Project such as:

- Business process documentation preparation and implementation
- Marketing information related to medical device
- Quality management system preparation and implementation for certification
- Product technical documentation preparation
- Product registration with country dossier preparation for world-wide submission, including new products, change/variation & renewals to the relevant authorities
- International Medical Device School training program activities

**Requirements/Qualifications**
- Bachelor's degree majoring in Pharmacy, Regulatory or related fields.
- Minimum 1 year experience.
- Skills - Technical Documentation, Usability, Sampling, Regulatory Compliance, Product Design, Quality Management, Quality Assurance, GMP, Investigation, Human Resource, Design Control, Business Process, Regulatory Requirements, Disposition, Strategy Planning, Manufacturing

Pay: RM2,200.00 - RM3,200.00 per month

Schedule:

- Monday to Friday



  • Johor Bahru, Malaysia Hemo Bioengineering Pte Ltd Full time

    Objective: Responsible for the management of regulatory submissions for new product registration as well as the notification of change of existing products registered in the APAC, European and US region, whilst ensuring compliance with the relevant legislation, industry standards and Company policies. Key Responsibilities: - Manage independently all...


  • Johor Bahru, Malaysia ARQon Pte Ltd Full time

    **Roles and Responsibilities** - Support regulatory compliance advisors in Therapeutic & Health Products, projects. Projects activities include: 1. Reviewing product technical documentation or technical file preparation on therapeutic and health products. 2. Product registration with country dossier preparation from the product technical documentation &...

  • Quality Manager

    6 months ago


    Johor Bahru, Malaysia Masimo Full time

    **Job Summary: The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement...


  • Johor Bahru, Malaysia Celestica Full time

    Req ID: 119775 Remote Position: No Region: Asia Country: Malaysia State/Province: Johor City: Johor Bahru **General Overview**: **Functional Area**: OPS - Operations **Career Stream**: QUA - Quality **Role**: Associate **SAP Short Name**: ASS **Job Title**: Quality Associate **Job Code**: AST-OPS-QUA **Job Level**: Band 06 **Profile-Holding**:...

  • Wireman / Electrician

    7 months ago


    Johor Bahru, Malaysia PAPILLA SDN BHD Full time

    Wiring and installing of electrical components for building - Must be able to read basic symbols and electrical diagrams. - Strong understanding of basic formula to calculate voltage and amps. - Strong knowledge of ladder diagrams, relay, time, heater, thermocouple, sensor, and PLC. - Must be confident in troubleshooting electrical errors in order to comply...


  • Johor Bahru, Malaysia Hemo Bioengineering Pte Ltd Full time

    **Position Overview**: **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of local and international regulatory requirements related to the project. - Monitor changes in regulations and communicate updates to relevant stakeholders. - Assist in developing project-specific strategies to ensure ongoing compliance with regulatory standards. -...


  • Johor Bahru, Malaysia Hemo Bioengineering Pte Ltd Full time

    **Position Overview**: **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of local and international regulatory requirements related to the project. - Monitor changes in regulations and communicate updates to relevant stakeholders. - Assist in developing project-specific strategies to ensure ongoing compliance with regulatory standards. -...

  • Associate Trainer

    6 months ago


    Johor Bahru, Malaysia MSTS Asia Sdn Bhd (Johor Center) Full time

    **ASSOCIATE TRAINER** **WE ARE HIRING**! At our Training Center in **JOHOR BAHRU** If you are a person who is. - **PASSIONATE** about **TRAINING** and loves **SHARING KNOWLEDGE** with others (possess **Train The Trainer (TTT)** Certificate) - **EXPERIENCED AND EXPOSED** in Safety Critical Industries (**Oil & Gas, Safety, Renewable Energy, Fire...

  • Associate Trainer

    5 months ago


    Johor Bahru, Malaysia MSTS Asia Sdn Bhd (Johor Center) Full time

    **ASSOCIATE TRAINER** **WE ARE HIRING**! At our Training Center in **JOHOR BAHRU** If you are a person who is. - **PASSIONATE** about **TRAINING** and loves **SHARING KNOWLEDGE** with others (possess **Train The Trainer (TTT)** Certificate) - **EXPERIENCED AND EXPOSED** in Safety Critical Industries (**Oil & Gas, Safety, Renewable Energy, Fire...

  • Quality Analyst

    5 months ago


    Johor Bahru, Malaysia JACOBS DOUWE EGBERTS Full time

    **Company Description**: - It’s amazing what can happen over a cup of coffee_. At **JACOBS DOUWE EGBERTS (JDE)**, we’ve made it our mission to find out. Our people have been raising the bar since day one, thinking fast and acting even faster to make an impact that’s felt around the world. JDE is the home to some of the most well-known coffee brands in...

  • Quality Analyst

    5 months ago


    Johor Bahru, Malaysia JACOBS DOUWE EGBERTS Full time

    Quality Analyst - Quality Management - Johor Bahru - Full-time - Malaysia The quality analyst performs quality checks on all key business processes from supplier to customer, from incoming raw and pack materials to finished products, to ensure goods produced comply to the standards set by the Quality Organization. **_ Main purpose_** - The Quality Analyst...


  • Johor Bahru, Malaysia JAC Recruitment Full time

    **JOB RESPONSIBILITIES** - To monitor and ensure company products and processes adhere to regulatory requirements by relevant government bodies and international standards. - To oversee and coordinate activities related to product labelling, content and security. - To identify and provide input on the impact of changes in regulations. **JOB REQUIREMENTS** -...


  • Johor Bahru, Malaysia Tiger Balm (Malaysia) Sdn Bhd Full time

    **Responsibilities**: **1. New product registration**: Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: - Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists. - Compile/ review/check material...


  • Johor Bahru, Johor, Malaysia Agensi Pekerjaan Minde Group Sdn Bhd Full time

    Job Title: QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)Location: Johor BahruCompany Overview:A leading manufacturer of pharmaceutical and medical packaging solutions, this company specializes in providing high-quality, customized packaging for the healthcare sector. They are well-established in Malaysia and Singapore and are known for their...


  • Johor Bahru, Johor, Malaysia Agensi Pekerjaan Minde Group Sdn Bhd Full time

    Quality Management System SpecialistWe are seeking a highly skilled Quality Management System Specialist to join our team at Agensi Pekerjaan Minde Group Sdn Bhd.Key Responsibilities:Develop and Implement Quality Management Systems: Design, implement, and maintain a quality management system that meets the requirements of ISO 9001 and IATF 16949.Conduct...


  • Johor Bahru, Malaysia TRANSYSTEM FA SDN BHD Full time

    **Define and Establish Quality Standards**: - Develop, implement, and maintain quality standards for products/services. - Collaborate with cross-functional teams to ensure a clear understanding of quality requirements. - **Testing and Inspection**: - Design and execute test plans to identify defects or deviations from quality standards. - Conduct thorough...

  • Audit & Tax Associate

    6 months ago


    Johor Bahru, Malaysia VH Associates Sdn Bhd Full time

    Are you a motivated and detail-oriented individual with a passion for accounting and finance? Do you thrive in a dynamic work environment that offers growth and professional development opportunities? If so, we have an exciting opportunity for you to join our team as an Audit & Tax Associate! **Company Overview**: At VentureHaven, we are a leading...


  • Johor Bahru, Malaysia TRANSYSTEM FA SDN BHD Full time

    **Define and Establish Quality Standards**: - Develop, implement, and maintain quality standards for products/services. - Collaborate with cross-functional teams to ensure a clear understanding of quality requirements. - **Testing and Inspection**: - Design and execute test plans to identify defects or deviations from quality standards. - Conduct thorough...


  • Johor Bahru, Malaysia Tiger Balm (Malaysia) Sdn Bhd Full time

    **Responsibilities**: - To support and perform Manager-delegate role in leading the Department to fulfill quality objectives and ensure the regulatory and customers’ requirements are met. - To ensure that the QA/QC systems and quality standards of products are maintained and constantly improved. - To support the operation of the Department effectively and...


  • Johor Bahru, Johor, Malaysia Agensi Pekerjaan Minde Group Sdn Bhd Full time

    Job Title: QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)Overview:Agensi Pekerjaan Minde Group Sdn Bhd, a leading manufacturer of pharmaceutical and medical packaging solutions, seeks a seasoned Quality Assurance Manager to join their team. The ideal candidate will possess strong leadership skills and expertise in ISO 13485 standards.Key...