Regulatory Affairs Manager

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...

**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. -...

**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** -...

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...

Oversee day-to-day office operations. - Lead and manage administrative staff. - Manage office space, maintenance, and vendor relationships. - Plan and organize corporate events and meetings. - Facilitate employee travel arrangements. - Ensure compliance with travel policies. - Establish and maintain efficient filing systems. - Safeguard confidentiality and...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. - Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. - Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. - Manage group...

To oversees a company's administrative operations, ensuring efficiency and smooth workflow. - Manage inventory of office supplies, PPE, and the purchasing of material with attention to budgetary constraints. - Manage total group overall procurement functions such as sourcing quotations, compare pricing, purchase orders and GRN issuance. - Manage group...

**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...

**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...

Branch managers are responsible for the management of all the affairs related with a company in a specific geographic region or business branch. They receive indications from the headquarters, and depending on the structure of the company, they aim to implement the strategy of the company while adapting it to the market where the branch operates. They...

JOB DESCRIPTION: - Coordinate & controlling activities related to trial/first production - Monitor activities related to standard preparation & update - Involve in jobs related to lab experiment, pilot plant trial & its waste management - **Monitor ISO management systems.**: - Supervise activities related to **standard product label design, content &...

Branch managers are responsible for the management of all the affairs related with a company in a specific geographic region or business branch. They receive indications from the headquarters, and depending on the structure of the company, they aim to implement the strategy of the company while adapting it to the market where the branch operates. They...

**Position Title : HR & GA General Manager** **Industry : Automotive Parts Manufacturing** **Location: Mak Mandin,Penang** **Salary Range: Up to RM20000** **Responsibilities**: 1. Oversee all administrative matters, including but not limited to human resources, succession plans, data management, legal, compliance and general affairs. 3. To interact with...

Coordinate & controlling activities related to trial/first production. - Monitor activities related to standard preparation & update. - Involve in jobs related to lab experiment, pilot plant trial & its waste management. - Monitor ISO management systems - Supervise activities related to standard product label design, content & security. - Monitoring,...

**Job. HR Manager - Johor Bahru** - Personnel recruitment: Review and implement talent recruitment based on employment needs, providing manpower support for company operations; - Employee training: Establish a training system and organize its implementation in accordance with ISO13485 and personnel reserve, training, and promotion requirements; - Salary...

**Responsibilities**: - Develop medico-legal related policies in alignment with JCI and MSQH requirements as well as Private Healthcare Services and Facilities Act in Malaysia. - Risk governance by working closely with Heads of Departments (HODs) on risk management and compliance programs. - Provide end-to-end legal advisory and drafting support to business...

You are invited to **deposit your resumes with us** and our recruiters shall reach out to you to discuss more. **Work location**:Nusajaya **What do we have for you?** - Bonuses, incentives & increments - 5 days' work - enjoy work-life balance - MNC working environment - Group insurance for dental and medical - Free lunch provided - Flexibility working...

**Job Purpose**: Coordinate academic-related matters of the centre. **Key Responsibilities & Accountabilities**: - To arrange class & lecturer schedule. - To handle academic relevant matters. - Oversee students’ affairs and welfare matters. - Coordinate with the Program Leader on academic matters. - To assist the centre manager in overseeing centre...

**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。 -...