
Regulatory Affairs Specialist
1 week ago
**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
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 Specialist
2 weeks ago
Singapore Reeracoen Singapore Pte Ltd Full timeJob title: Regulatory Affairs Specialist Reference ID: 36639 Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and...
-
Regulatory Affairs Specialist
23 hours ago
Singapore ALCOTECH PTE. LTD. Full timeAlcotech 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
22 hours ago
Singapore ALCOTECH PTE. LTD. Full timeAlcotech 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 beBeeRegulatory Full time $80,000 - $140,000Job Title: Regulatory Affairs Specialist">This is a unique opportunity to leverage your expertise in regulatory affairs and medical writing to drive business success.The ideal candidate will possess strong analytical skills, excellent communication abilities, and the ability to work effectively in a collaborative environment.">Responsibilities:">Develop...
-
Regulatory Affairs Specialist
2 weeks ago
Singapore Johnson & Johnson Full timeCaring 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 weeks 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 Professional
2 weeks ago
Singapore beBeeRegulatory Full timeRegulatory 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...
-
Surveillance Regulatory Affairs Officer
4 weeks ago
Singapore Marina Bay Sands Full timeJoin to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and...
-
Regulatory Affairs Compliance Officer
2 weeks ago
Singapore beBeeRegulatory Full time $70,000 - $101,000Regulatory Affairs Specialist Role OverviewThis is an exciting opportunity for a highly skilled Regulatory Affairs Specialist to join our organization. As a key member of the regulatory team, you will play a pivotal role in ensuring compliance with regulatory requirements and facilitating the registration of products in designated countries.