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Ra&qa Executive

2 weeks ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**THE ROLE**:
The RA&QA Executive will be responsible for regulatory compliance of IVD devices and related products according to relevant medical device regulations. Also, the RA&QA Executive will also be acting as a cross-department liaison with internal and external stakeholders, including distributors in the ASEAN region.

**OVERVIEW OF KEY REPONSIBILITIES**:

- Responsible for preparing and submitting product registration for Class A to D IVD with health authorities in a timely manner
- Perform RA activities pertaining to product certification through renewal, licence amendments and new registration for the ASEAN region
- Work in tandem with the Global RA team, requesting support as necessary while overseeing the administration of local regulatory systems and processes
- Extend regulatory support to other departments such as marketing and sales colleagues
- In charge of QMS management and post-market surveillance activities including FSCA, CAPA, recall management and customer complaints
- Support internal and external quality audits
- Oversee quality assurance of product importation, labelling, warehouse and distribution

**REQUIREMENTS**:

- Relevant Bachelor’s degree e.g. Engineering, Biomedical Sciences
- At least 3-5 years’ experience in the medical devices industry with regional responsibilities
- Demonstrated success in regulatory submissions
- Knowledge of SS 620:2016 GDPMDS or ISO 13485
- RAPS certifications is an added advantage

**HOW TO APPLY**:
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502