Regulatory Affairs

1 day ago

Singapore SCHULKE & MAYR (ASIA) PTE LTD Full time

**Responsibilities**:

- Obtain timely renewal of product licenses and maintain registration database
- Ensure appropriate licensing, regulatory, marketing and legal compliance of products in each country with the support of local regulatory/distribution partner
- Liaise with regulatory bodies and distribution partners in the region to maintain product licenses to allow sales activities in these countries
- Ensure product labels and materials are compliant with regulatory requirements
- Provide training on regulatory and quality topics when necessary
- Ensure compliance of local government requirements and responsible for QMS maintenance and update for entity e.g. Good distribution and practices for medical device.
- Responsible for quality review and batch test reports for quality release
- Responsible for internal audits across entities and external audits with warehouse partners, manufacturing suppliers
- Lead for outsourcing projects where tech transfers, quality audits and preparation of dossiers are necessary working with key stakeholders in Quality and regulatory departments of manufacturers and respective local requirements
- Provide regulatory strategies for new products and any changes in targeted markets
- Setting up SOPs and ensure product quality and feedback on quality are well managed
- Supervise and guide 1 x Regulatory Affairs and Quality Assurance Executive

**Requirements**:

- Possess relevant Degree with at least 5-8 years of Regulatory Affairs/Quality Assurance experience working for medical device companies
- Possess knowledge of regulatory guidelines and requirement of countries in ASEAN as well as Quality Management System and GDPMD.
- Experience in audits and well verse in requirements on cosmetic GMP, ISO13485 and WHO GMP requirements
- Experience in tech transfer and manufacturing process is preferred
- Available on a short notice

  • Regulatory Affairs Specialist

    4 days ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Affairs Director

    1 week ago

    Singapore PharmEng Technology Full time

    **Regulatory Affairs Director** Join a leading global organization as a **Regulatory Affairs Director**, shaping regulatory strategies across multiple regions. This high-impact role ensures compliance, drives regulatory approvals, and collaborates with senior leadership and health authorities worldwide. **Key Responsibilities**: Develop and implement...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

  • Regulatory Affairs

    4 weeks ago

    Singapore SCIMED (ASIA) PTE LTD Full time

    Roles & ResponsibilitiesPrincipal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management...

  • Regulatory Affairs Executive

    2 weeks ago

    Singapore Hays Full time

    **Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...

  • Regulatory Affairs Specialist

    5 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Associate

    4 weeks ago

    Singapore PRESTIGE BIOPHARMA LIMITED Full time

    Roles & ResponsibilitiesJob Description & RequirementsReporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.Responsibilities· Assist with submission of applications and variations for clinical trials and marketing authorisation across all...

  • Regulatory Affairs Specialist

    2 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...

  • Regulatory Affairs Specialist

    5 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    2 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...