Regulatory Affairs Specialist (Worked in HSA or experiencedin RA)

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

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.