Regulatory Affairs Associate

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...

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 government...

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 for dossier prior...

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 projectspecific strategies to ensure ongoing compliance with regulatory standards.- Documentation and...

**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...

**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. -...

**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. -...

**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. -...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

**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** -...

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 Bachelor's Degree...

**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...

**工作職責:****1、新產品註冊:**- 根據相關監管要求準備和編制註冊檔案,包括:- 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。- 在提交之前編譯/審查/檢查檔案資料,納入相關利害關係人的回饋。- 對藝術品進行檢查,以確保符合當地法規。-...

**Role** As a **Compliance Associate**, you will collaborate closely with Corporate Secretarial Team on ongoing compliance matters. Compliance Associate will play a vital role in ensuring that the organization adheres to relevant laws, regulations, and industry standards. You will be in charge of both projects and ad hoc daily tasks. The position will...

Develop, implement, and maintain a robust quality management system in accordance with industry standards and regulatory requirements. - Identify opportunities for process improvements and lead initiatives to enhance efficiency and effectiveness. - Foster a culture of quality, accountability, and continuous improvement within the organization. Compliance and...

**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** **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...

Assists in providing outstanding service to our clients and performs many entry level accounting duties. To handle full statutory auditing and accounting assigment independently - Assist in planning multiple audit assignments. Establish, maintain and strengthen internal and external relationships, execute complex assurance procedures - Assist to oversee...

**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...

Assists in providing outstanding service to our clients and performs many entry level accounting duties. To handle full statutory auditing and accounting assigment independently Assist in planning multiple audit assignments. Establish, maintain and strengthen internal and external relationships, execute complex assurance procedures Assist to oversee day to...