Regulatory Affairs Specialist

10 hours 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**:
**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, labeling, 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 Chinese is a requirement.
- 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.

  • Regulatory Affairs Specialist

    4 days ago

    Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

  • Regulatory Affairs Specialist

    2 days ago

    Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

    **PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...

  • Regulatory Affairs

    2 weeks ago

    Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $5,000 - $10,000 Per Month **Date Posted** 6 minutes ago Additional Details **Job ID** 3010 **Job Views** 1 Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting multiple...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Reeracoen Singapore Pte Ltd Full time

    Our client is Medical medical devices company and now they are looking for Regulatory Affairs Specialist. You will be reporting to Regulatory Affairs Manager 【 What you will be doing 】 - Responding to company policy and company requirements, propose strategic regulatory - Assess regulatory requirements and develop regulatory strategies for the...

  • Specialist, Regulatory Affairs

    2 days ago

    Singapore MSD Full time

    **Specialist, Regulatory Affairs** **THE OPPORTUNITY** - Based in Singapore, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021). - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our...

  • Junior Regulatory Affairs Specialist

    10 hours ago

    Singapore Andaman Medical Full time

    We are looking for a Regulatory Affairs Specialist with at least 1 year experience in medical devices and or any related field, who can further assist our team in Thailand in processing medical device registration, determining risk classifications of health products and monitoring trends regarding the industry regulations. - Preparing and submitting...

  • Specialist, Regulatory Affairs

    1 week ago

    Singapore ResMed Full time $80,000 - $120,000 per year

    About ResMedAt ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...

  • Quality and Regulatory Affairs Specialist

    2 weeks ago

    Singapore MAJETON PTE. LTD. Full time

    At Majeton, weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality & Regulatory Affairs...

  • Quality and Regulatory Affairs Specialist

    3 days ago

    Singapore MAJETON PTE. LTD. Full time

    Roles & Responsibilities At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality...

  • Regulatory Affairs Specialist

    6 days ago

    Singapore AITBIOTECH PTE. LTD. Full time

    **Regulatory Affairs Specialist **Responsibilities**: - Responsible for regulatory activities - Collaborates with cross-functional departments to ensure timely implementation of document change requests - Develop and establish policies and standards that convey the best practices in the company - Work closely with lab and sales team to help drive quality...