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.
- **Documentation and Submission**:

- Maintain accurate and up-to-date regulatory documentation for the project, ensuring accessibility for audits.
- **Communication with Regulatory Authorities**:

- Act as a liaison between the company and regulatory agencies for matters specific to the project.
- Respond to queries and requests for additional information from regulatory authorities promptly.
- **Quality Assurance Support**:

- Collaborate with quality assurance teams to ensure project-related products meet regulatory standards.
- Participate in internal and external quality audits related to regulatory affairs for the project.
- **Labeling and Packaging Compliance**:

- Review and approve product labeling and packaging materials for compliance with regulatory requirements for the project.
- **Cross-functional Collaboration**:

- Work closely with cross-functional teams involved in the project, including R&D, marketing, and legal, to ensure regulatory considerations are integrated into project strategies.
- **Regulatory Intelligence and Research**:

- Conduct regulatory intelligence activities specific to the project to anticipate regulatory trends and potential impacts.
- Engage in research work related to product development, manufacturing, and intellectual property within the scope of the project.

**Qualifications**:

- Bachelor's degree in a relevant scientific or regulatory field.
- Proven experience as a Regulatory Affairs Specialist
- Strong understanding of local and international regulatory frameworks.
- Experience in intellectual property-related work.
- Excellent written and verbal communication skills.
- Detail-oriented with a commitment to maintaining accurate and organized records.
- Ability to work independently and collaboratively in a fast-paced environment.

**Contract Duration**:
The initial contract period will be 12 months, with the possibility of extension based on the project timeline, performance, and business needs.

**Job Types**: Full-time, Contract
Contract length: 12 months

**Salary**: RM3,500.00 - RM5,000.00 per month

Schedule:

- Monday to Friday

**Language**:

- Mandarin (required)



  • 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

    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 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, 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, Malaysia Thermo Fisher Scientific Full time

    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...

  • 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...


  • Johor Bahru, Malaysia Regency Specialist Hospital Full time

    **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...


  • 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...


  • 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...


  • Johor Bahru, Malaysia Agensi Pekerjaan GMRecruitment Sdn Bhd Full time

    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...

  • Admin Affair Manager

    6 months ago


    Johor Bahru, Malaysia Agensi Pekerjaan GMRecruitment Sdn Bhd Full time

    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...


  • Johor Bahru, Johor, Malaysia Talent Recruit Full time

    Company Overview:Talent Recruit is a leading recruitment agency specializing in placing top talent in the marine and offshore industry.We are currently seeking an experienced Electrical Systems Specialist to join our team.Salary:The estimated salary for this role is $120,000 - $150,000 per annum, depending on experience.Job Description:As an Electrical...

  • Project Specialist

    4 weeks ago


    Johor Bahru, Johor, Malaysia Upright Talent Full time

    Your RoleDrive technical and management aspects of projects from initiation to completion.About UsUpright Talent is a leading talent acquisition partner in the industry, committed to delivering top-notch professionals who drive business success.We are currently seeking an experienced Project Specialist to join our team!Key ResponsibilitiesCoordinate project...


  • Johor Bahru, Johor, Malaysia Nala Groups Full time

    **Job Overview:**Nala Groups is seeking a highly skilled Industrial Quality Specialist to join our team in Desa Cemerlang JB. As an essential member of our manufacturing department, you will be responsible for ensuring the highest quality standards are met throughout the production process.**Key Responsibilities:**Liaise with customers and suppliers to...

  • Project Admin

    6 months ago


    Johor Bahru, Malaysia JLAND GROUP Full time

    Provide comprehensive administrative support to project managers and the construction team. Manage project documentation, including contracts, plans, and reports. Maintain accurate and up-to-date records of project activities and correspondence. - Coordinate meetings, schedules, and appointments for the project team. Communicate effectively with internal and...


  • Johor Bahru, Malaysia Yuwen Resources Full time

    **Location**: Remote **Working Hours**: Full-time, 5 days per week, 3 weekdays, and 2 weekends (Monday to Friday: 10 AM—7 PM; Saturday and Sunday: 9 AM—6 PM). **Job Overview** Join our team as an _**Academic Management Specialist**_ and be part of a dynamic tuition centre that prides itself on a Customer-Centric approach, fostering a Performance...


  • Johor Bahru, Johor, Malaysia J-Recruit Recruitment Agency Full time

    About J-Recruit Recruitment Agency:We are a reputable recruitment agency based in Senai, operating in the Other Food Manufacturing sector. Established on September 19, 2001, our company provides top talent to various industries.Salary : RM2500 - RM3500 per monthWorking Hours : Monday to Friday 8:30am - 5:30pm, Saturday 8:30am - 12:30pmJob Responsibilities:We...


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

    Job Summary: We are seeking a highly motivated and experienced Environmental Health and Safety Specialist to join our team at Agensi Pekerjaan Minde Group Sdn Bhd. The successful candidate will be responsible for ensuring compliance with regulatory requirements, conducting risk assessments, and enforcing preventive measures to maintain a safe and healthy...

  • Project Manager

    6 months ago


    Johor Bahru, Malaysia Sika Full time

    **Company Description** In the Construction sector, our business activities cover the full spectrum of project types ranging from infrastructural development to buildings, from institutional facilities to manufacturing plants. We service our direct customers - concrete producers, contractors and distributors - and stay close to them through our central...


  • Johor Bahru, Malaysia TenneT Full time

    TenneT is growing fast to realize its strategic ambitions. We play a leading role in driving the energy transition. We are looking for a passionate Sub Project Lead Construction at our yard location in Johor Bahru - Malaysia who will contribute to this and that might be you? **Your contribution to TenneT**: The Sub-project Lead Construction is working in...