Regulatory Affairs

2 weeks ago

Singapore RESPIREE PTE. LTD. Full time

**Roles & Responsibilities**

The RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross
- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and regulatory strategies are effectively implemented and quality systems are maintained and improved.

**Key Responsibilities**:
(a) Prepare good quality technical documentation.

(b) Manage regulatory submissions for pre-market product registration, renewals, and amendments to ensure timely market entry and compliance.

(c) Stay up to date on evolving regulations and guidelines and provide guidance to internal teams on regulatory landscape.

(d) Monitor post
- market surveillance and timely reporting to regulatory authorities.

(e) Prepare and support internal audits, regulatory inspections and audits by notified body, regulatory agencies, partners, and addressing any findings or non
- compliance issues that arise.

(f) Support supplier management and audits.

(g) Manage and maintain the effectiveness of Quality Management System (ISO 13485).

(h) Develop, implement and maintain SOPs and quality processes.

(i) Provide training to employees on regulatory and quality requirements.

(j) Responsible for database, processes and systems within RAQA.

**Qualifications and Competency**

(a) At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field.

(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry.

(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)

(d) Strong knowledge and understanding of ISO 13485, GMP, regulatory and quality standards

(e) Excellent project management, organizational and problem solving skills

(f) Strong attention to details with the ability to manage multiple priorities and deadlines.

(g) Excellent written and verbal communication skills

(h) Proficient in Microsoft Office

(i) Background in medical device manufacturing would be an added advantage.

  • Regulatory Affairs Manager

    2 weeks ago

    Singapore Artixio Consulting Pvt Ltd Full time

    This is a full-time hybrid role as a Regulatory Affairs Manager at Artixio. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining quality systems. The role is based in Singapore but allows for some remote work. **Qualifications** - Minimum...

  • Regulatory Affairs Director

    4 days 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

    3 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

    1 week 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

    1 day 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

    3 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...

  • Associate, Regulatory Affairs

    2 weeks ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    **About APACMed** Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully committed to facilitating...

  • Regulatory Affairs Specialist

    1 day 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 weeks ago

    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...

  • Regulatory Affairs Professional

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist RoleWe are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our regulatory activities.This role will involve assisting with the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.Main Responsibilities:Submission Support: Assist with the...