REGULATORY AFFAIRS EXECUTIVE

1. Communicate with regulatory bodies on regulatory affairs (e.g. product registration, change notifications)
2. Communicate with team members on required regulatory requirements during product development
3. Dossier preparation and submission for product registration
4. Support post-market activities (e.g. customer complaint, post-market surveillance, adverse events, field safety corrective action)
5. Support regulatory inspections/audits
6. Read, analyze and interpret respective medical device regulations
7. Keep up to date with regulatory affairs. Monitor and evaluate impact of any new or changing regulatory environment/landscape in regions of interests
8. Other ad-hoc duties related to regulatory affairs (e.g. artwork approval, change control impact analysis)

1. Degree in Life Science, Bioengineering, Biotechnology or a related discipline
2. Good knowledge in:

• Immunoassay and Clinical Chemistry IVD
• Regulatory requirements of ASEAN countries and EU
• IVD standards and guidelines (e.g. CLSI, ISO 62366)

1. At least 3 years working experience in medical device registration with Health Sciences Authority
2. Experience in medical device registration in ASEAN countries and EU will be a plus
3. Experience working in an ISO 13485 environment will be a plus.

1. Able to work independently and in a cross functional team
2. Able to communicate effectively
3. Well organized with good documentation habits
4. Proactive, responsible, results driven, highly self-motivated, adaptable and a self-learner

Applicants with extensive experience may be offered a senior position.