Project Regulatory Affairs Specialist

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...

**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. -...

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...

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...

**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 &...

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...

**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...

**Responsibilities**: - Develop communication platform to promote the establishment and maintenance of meaningful communications and facilitate dialogues between customers, patients and families, team members, consultants, and other relevant parties. - To gather In & Out patient feedbacks on daily basis, check which feedback need to be follow up and update...

**Responsibilities**: - Plan and coordinate marketing event and promotion activities with business associate, NGOs, ARO and any potential business partner by market segment. Utilize all the resource to maximize the marketing outcome. - Liaise with media partner for wider market outreach including to prepare media content. - Collaborate with Regency...

**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...

Responsibilities: Develop medicolegal 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 endtoend legal advisory and drafting support to business development...

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 insurance...

Responsibilities: Plan and coordinate marketing event and promotion activities with business associate, NGOs, ARO and any potential business partner by market segment. Utilize all the resource to maximize the marketing outcome. Liaise with media partner for wider market outreach including to prepare media content. Collaborate with Regency Specialist Hospital...

**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。-...

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...