Regulatory Affairs

5 months ago

Ipoh, Malaysia AGENSI PEKERJAAN RECRUIT ADVANCE SDN BHD Full time

1) To assist in registration/approval for the medical devices in different countries.

2) Maintain internal and source company databases of regulatory approvals

3) Preparation of dossiers and on-time submissions to the local health authority in accordance with Marketing launch plans and global timelines.

4) To ensure understanding of regulatory requirements and request the documentation required for registration submissions

5) Liaise with regulatory authorities and designated agents on all registration matters including to the Malaysian medical device regulatory requirements.

7) Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio

8) Keep internal team members updated with the complying medical devices regulatory news and update, guidelines and etc.

9) Facilitate/ track the preparation and submissions of regulatory documents, registration dossiers, licenses for manufacturing facility, etc. to support the projects.

10) To support all EU MDR related matters-main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745.

11) Act as the Person Responsible for Regulatory Compliance (PRRC) for Sanctuary Health Sdn Bhd in respect of the EU MDR issues.

12) Act as Internal Auditor during internal audits for complying regulation.

13) Any other tasks as assigned by the reporting superior

**Salary**: RM2,500.00 - RM3,000.00 per month

**Benefits**:

- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Day shift

Supplemental pay types:

- Attendance bonus
- Commission pay
- Overtime pay
- Performance bonus

Ability to commute/relocate:

- Ipoh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- QA/QC: 1 year (preferred)

  • Regulatory Affairs Executive

    5 months ago

    Ipoh, Malaysia Hovid Berhad Full time

    **Responsibilities**: 1. Assist in Registration Matters (a) Obtaining and maintaining marketing authorizations for all categories of products regulated by drug regulatory authorities worldwide. i.) Organising and producing product dossiers for regulatory submission for designated countries. ii.) Liaising with regulatory authorities and...

  • Business Development Regulatory Affairs Executive

    5 months ago

    Ipoh, Malaysia Hovid Berhad Full time

    **Responsibilities**: - Develop and maintain business relationships with new and existing OEM Business Partners. - Conduct market research and obtain sales forecast from sales team to evaluate market potential of OEM products. - Coordinate with customers (Internal departments i.e., Sales and Marketing, International Business Division) on OEM-related...

  • Regulatory Affairs Internship/assistant

    5 months ago

    Ipoh, Malaysia Wan Yeen Group Of Companies Full time

    1. Ensure all the products compliance with NPRA as DRGD guidelines 2. Register new Mal Application 4. Ensure the product label, outer box and leaflets information compliance with NPRA Standards 5. Monitor regulatory maintenance (renewal of TOKEN, Products's Mal Renewal) 4. Assist any registration and team leader for NPRA audit **Job Type**:...

  • Product Trainer

    4 months ago

    Ipoh, Malaysia Eltean Incorporated Sdn Bhd Full time

    **What is this job about?** **Product Training** - Assist in developing sales team’s selling technique and product knowledge - Teaching presentation and persuasion techniques to new sales and marketing hires - Design and conduct: 1) onboarding training session for new sales and marketing hires and - 2) periodic training sessions for existing sales and...

  • Product Trainer

    5 months ago

    Ipoh, Malaysia Eltean Incorporated Sdn Bhd Full time

    **Product Training** - Design and conduct 1) on boarding training session for new sales and marketing hires including teaching presentation and persuasion technique, role play to simulate sales scenarios 2) periodic training sessions for existing sales and marketing teams - Assist in developing sales team’s selling technique and product knowledge -...

  • Provisionally Registered Pharmacist

    5 months ago

    Ipoh, Malaysia Hovid Berhad Full time

    The PRP Program will be a good platform to grow in different segments of the industry. The segments include Operations, Sales & Marketing, Business Development, Regulatory Affairs, Quality Control and Quality Assurance. The PRP’s learning journey at Hovid Berhad is opened to wider opportunities that will help the PRP to cultivate skills and capabilities to...

  • Junior Executive HR and Admin

    4 months ago

    Ipoh, Malaysia Lian Choon Huat Metal Industries Sdn Bhd Full time

    **Responsibilities**: - Support recruitment process of local and foreign workers and contract documentation, attendance and leave balances for Group payroll and reporting function. - Assist to liaise with recruitment agencies to facilitate renewal of permits, working passes, visas and other matters relating to MOHR, MOHA and FWCMS- Handle medical and...

  • Junior Executive HR and Admin

    4 months ago

    Ipoh, Malaysia Lian Choon Huat Hardware Sdn Bhd Full time

    **Responsibilities**: - Support recruitment process of local and foreign workers and contract documentation, attendance and leave balances for Group payroll and reporting function. - Assist to liaise with recruitment agencies to facilitate renewal of permits, working passes, visas and other matters relating to MOHR, MOHA and FWCMS- Handle medical and...

  • Sr Medical Sales Specialist

    4 weeks ago

    Ipoh, Perak, Malaysia Abbott Laboratories Full time

    Job DescriptionPRIMARY FUNCTION:Maintain deep, current knowledge about diabetes management, especially diabetes monitoring devices and digital tools, the evolving healthcare landscape, and emerging digital trends to support selling and educating a broad and deep network of HCPs about Abbott productsContribute to the long-term growth of Abbott Diabetes Care...

  • Sr Medical Sales Specialist

    2 months ago

    Ipoh, Malaysia Abbott Laboratories Full time

    Job DescriptionPRIMARY FUNCTION:Maintain deep, current knowledge about diabetes management, especially diabetes monitoring devices and digital tools, the evolving healthcare landscape, and emerging digital trends to support selling and educating a broad and deep network of HCPs about Abbott productsContribute to the long-term growth of Abbott Diabetes Care...