Regulatory Affairs Executive

Job Responsibilities

Manage medical device and IVD product registrations, including preparation and submission of regulatory dossiers.

Handle regulatory submissions to Health Sciences Authority (HSA) and support registrations in other countries where applicable.

Communicate with regulatory authorities (e.g. HSA, MDA, FDA) to track submission progress and respond to queries during the review process.

Support regulatory activities related to product testing, performance evaluation studies, and clinical verification, including coordination with CROs where required.

Ensure regulatory documentation complies with relevant medical device regulations and standards.

Work closely with R&D, Quality, and other internal teams to support product development and commercialization.

Keep track of regulatory updates and requirements relevant to the company's products.

Perform other regulatory or project-related duties assigned by management.

Job Requirements

Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, or a related field.

Experience in medical device or IVD regulatory affairs.

Hands-on experience with HSA product registration is required.

Experience with other countries regulatory submissions (e.g. ASEAN, FDA, CE) is an advantage.

Familiar with ISO 13485 quality management system and medical device regulatory requirements.

Experience with Class B, C or D medical devices will be beneficial.

Familiarity with IVD products such as lateral flow, PCR, or immunoassay is preferred.