Regulatory Affairs Specialist

6 hours ago

Singapore EVYD RESEARCH PRIVATE LIMITED Full time

**JOB TITLE: Regulatory Affairs Specialist
**REPORTING TO**:Regulatory Director (Population Health)

**IN BRIEF**
- Reports to Regulatory Director, responsible for EVYD’s regulatory affairs.
- Regulatory affairs largely related to internal processes of medical device and non-medical device projects
- Looking at Software as a Medical Device (SaMD)

**KEY DELIVERABLES**
- FDA / CE / HSA (Singapore) approval, submissions, communications
- Standard operating processes for internal projects, both medical device related and non-medical device related.

**KEY RESPONSIBILITIES**:

- Responsible for the implementation and compliance of Quality Management System
- Keep up to date with latest standards related to medical device regulations and ensure compliance of processes to existing regulations
- Work with other departments to execute strong regulatory processes and manage internal stakeholders

**REQUIREMENTS**:

- 5 years of experience in Regulatory Affairs, with experience in SaMD

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