Regulatory Affairs Associate
6 months ago
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 product registrations/ change notifications/ re-registrations/ license renewals/ input requests-questions and other related actions to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans.
- Prepare, submit, and follow up with consultations on applicable regulations on company products and processes.
- Support customers/ dealers/ partners in our markets likewise where company entity is not the product holder and ensure their timely registration/ license renewal success.
- Maintain regulatory trackers and manage the filing and record keeping of regulatory documentation.
- Implementing quality strategy and strategic operational goals to meet quality objectives
- Thorough understanding of the legislation and medical device standards in our target markets to ensure best business outcomes.
- Identify and assess potential changes to relevant legislation and medical device standards within our target market regions and effectively communicate the impact to key stakeholders.
- Supporting Post Market Activity (PMS, PSUR annual updates) and ensuring timely and correct reporting/ follow up to authority.
- Keeping abreast of regulatory procedures and changes in the regions, advise and strategize with upper management, keeping them informed of the regulatory development and advising on the methods to execute contingency methods as needed.
- Responsible for coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections and attending to external auditor.
- Develop and review internal policies that relating to the manufacturing, testing, sales & marketing and reliability of products to ensure compliance of the regulatory requirements.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Acts as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs for submissions.
- Establish and support a work environment of continuous improvement that supports Company's Quality Policy, Quality Management System and the appropriate regulations for the area they support.
- Any other ad hoc projects as assigned.
Requirement:
- Minimum bachelor’s Degree in pharmacy, biomedical sciences or related studies. Fresh Degree Holder are welcome.
- Prior working experience in regulatory affairs function in the relevant industry is preferred.
- Good communication, negotiation and co-ordination skills are required to liaise with internal and external colleagues and service providers.
- Excellent planning and time management skills.
- Meticulous and attention for details.
- Be a team player, with excellent administration skills.
- Regulation knowledge on medical devices.
- Proactively seeks to develop and become well-versed within the regulatory landscape.
- Able to communicate and translate Technical documents from Chinese to English for relevant regulatory submission.
**Job Type**: Contract
Pay: RM4,000.00 - RM6,000.00 per month
Schedule:
- Monday to Friday
**Language**:
- Mandarin (required)
-
Regulatory Affairs Manager
6 months ago
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...
-
Project Regulatory Affairs Specialist
6 months ago
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. -...
-
Project Regulatory Affairs Specialist
6 months ago
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. -...
-
Reg Affairs Associate/director
6 months ago
Johor, Malaysia Thermo Fisher Scientific Full timeAt 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...
-
Regulatory Affaris Executive
6 months ago
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** -...
-
Regulatory & Quality Associate
6 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...
-
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
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...
-
Audit & Tax Associate
6 months ago
Johor Bahru, Malaysia VH Associates Sdn Bhd Full timeAre 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...
-
Quality Manager
7 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...
-
Associate, Business Development
6 months ago
Johor Bahru, Malaysia Great Eastern Malaysia Full timeAssociate, Business Development (GEGM Agency Distribution-Johor Bahru) **Discover the GREAT in your career.** As a LIFE company, our customers are at the heart of all that we do. Being one of Asia's leading insurer for over a century, we have built a long-lasting legacy of trust with our customers over many generations. At the foundation of this trust is...
-
Production Executive
6 months ago
Johor Bahru, Malaysia Agensi Pekerjaan My Recruit Direct Sdn Bhd Full timeJOB 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 &...
-
Lawyer
7 months ago
Johor Bahru, Malaysia Regency Specialist Hospital Full time**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...
-
06 - HR Associate
6 months ago
Johor Bahru, Malaysia Celestica Full timeReq ID: 117985 Remote Position: No Region: Asia Country: Malaysia State/Province: Johor City: Johor Bahru - CJA **General Overview**: **Functional Area**: HRM - Human Resources **Career Stream**: HRM - Human Resources **Role**: Associate **Job Title**: HR Associate **Job Code**: ASS-HRM **Band**: Level 06 **Direct/Indirect Indicator**:...
-
Technical & Product Compliance Executive (Food)
6 months ago
Johor Bahru, Malaysia Agensi Pekerjaan My Recruit Direct Sdn Bhd Full timeCoordinate & 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,...
-
Assistant Manager, International Marketing
6 months ago
Johor Bahru, Malaysia Regency Specialist Hospital Full time**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...
-
Shipping Coordinator
6 months ago
Johor Bahru, Malaysia Pro-Select Recruit Full timeYou 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...
-
Regulatory Affairs Manager
6 months ago
Johor Bahru, Malaysia Tiger Balm (Malaysia) Sdn Bhd Full time**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。 -...
-
Marketing Executive
6 months ago
Johor Bahru, Malaysia AllISWELL SDN BHD Full time**Overview**: As a Marketing Executive specializing in the healthcare sector, you will play a crucial role in developing and executing marketing strategies tailored to the unique needs and challenges of the healthcare industry. Your primary objective will be to promote healthcare products, services, or facilities to targeted audiences, including healthcare...
-
Remittance Executive
6 months ago
Johor Bahru, Malaysia Sinergia Talents Sdn Bhd Full time**Position Overview**: As a Remittance Executive, you will be responsible for facilitating efficient and timely transfer of funds domestically and internationally, ensuring compliance with regulatory requirements and providing exceptional customer service. This role requires meticulous attention to detail, strong communication skills, and the ability to work...