Medical Device Compliance Trainer

Job Overview

Responsible for designing and delivering Singapore medical device compliance training for Party A's project team, covering HSA regulations, product registration, quality systems, technical documentation, import, labeling, postmarket surveillance, and mutual recognition with EU/US/Australia, to support smooth product entry and ongoing compliance in Singapore.

Key Responsibilities

- Develop and deliver professional compliance training tailored to Party A's products, focused on Singapore's medical device regulatory system.

- Interpret HSA regulatory framework, Health Products Act (HPA), and latest regulatory policies.

- Explain A/B/C/D risk classification, registration pathways, application processes, and approval timelines.

- Train on ISO 13485 implementation and its linkage to medical device registration.

- Guide preparation of Technical Documentation (TD), clinical evaluation, ISO 10993 biocompatibility, IEC 60601 electrical safety.

- Cover import license, MEDICS system, labeling and IFU compliance requirements.

- Provide training on adverse event reporting, vigilance system, and postmarketing surveillance (PMS).

- Introduce mutual recognition policies with CE, FDA, TGA to speed up product approval.

- Address special compliance for highrisk devices (e.g., surgical robots) with realworld cases.

- Conduct training, collect feedback, update materials, and ensure training effectiveness.

Requirements

- Bachelor's degree in Biomedical Engineering, Medicine, Pharmacy, Regulatory Affairs or related.

- Professional knowledge of Singapore HSA medical device regulations, registration and compliance.

- Experience in regulatory training, technical dossier development, or medical device registration.

- Familiarity with ISO 13485, ISO 10993, IEC 60601, and global regulatory pathways.

- Good English communication, presentation, and training material development skills.

- Detailoriented, responsible, and able to support clientfocused compliance projects.

Preferred

- Experience serving overseas clients / Party A partners

- Highrisk medical device regulatory experience

- Practical MEDICS system operation experience

Employment Type

Part-time | Remote