Regulatory Affairs Specialist

2 weeks ago

Singapore ALCOTECH PTE. LTD. Full time
Roles & Responsibilities

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 Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

Key Responsibilities
  • Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
  • Advise on regulatory strategy, product classification, labelling, and compliance requirements.
  • Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
  • Support post-market surveillance activities.
  • Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.
Requirements
  • Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
  • Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
  • Ability in speaking both English and Chinese is a requirement. We have clients all over the world.
  • Strong organizational and project management skills; able to handle multiple submissions simultaneously.
  • Familiarity with Therapeutic Products License (TPL) is preferred.
Work Environment
  • Office-based role
  • Monday – Friday, 9:00 am – 6:00 pm
  • Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore 658066
Salary

$4,100 – $5,300 monthly, based on experience

Why Join Us
  • Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
  • Work closely with clients and regulatory authorities in a high-impact role.
  • Gain exposure to ASEAN regulatory environments while building professional expertise.
  • Join a specialist regulatory company offering career growth and professional development opportunities.
Tell employers what skills you have

Management Skills
Regulatory Compliance
Interpersonal Skills
Regulatory Affairs
ISO
Regulatory Strategy
Market Access
Biomedical Engineering
Clinical Trials
Surveillance
Compliance
Project Management
Medical Devices
Audits
Regulatory Requirements
Health Sciences
Regulatory Submissions

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist Job Description This is a comprehensive overview of the key responsibilities and deliverables for the Regulatory Affairs Specialist role.

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time $3,000 - $6,000

    Regulatory Affairs SpecialistWe are seeking a detail-oriented and organized Regulatory Affairs Specialist to join our team. The successful candidate will assist in regulatory activities for clinical trials and marketing authorisation.This is an excellent opportunity to develop your skills and knowledge in the field of Regulatory Affairs, working closely with...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore EVYD RESEARCH PRIVATE LIMITED Full time

    **JOB TITLE: Regulatory Affairs Specialist **REPORTING TO**:Regulatory Director (Population Health) **IN BRIEF** - Reports to Regulatory Director, responsible for EVYD’s regulatory affairs. - Regulatory affairs largely related to internal processes of medical device and non-medical device projects - Looking at Software as a Medical Device (SaMD) **KEY...

  • Regulatory Affairs Specialist

    3 weeks ago

    Singapore ProductLife Group Full time

    We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time $80,000 - $120,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a fast-paced environment.Job Description:Develop and implement regulatory strategies for new and existing...

  • Regulatory Affairs Specialist

    2 weeks 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

    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...

  • Regulatory Affairs Specialist

    1 week 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

    7 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

    7 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...