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**:
**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.

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