Regulatory Affairs Specialist (Medical Devices)

• Japanese Medical Devices manufacturer
• New headcount due to expansion of RA/QA team
• Minimum 1 - 3 years of Regulatory Affairs experiences

We are working with a JapaneseMedical Devices MNC with a strong vision to provide high quality standards and innovations. They have a staff strength of over 20,000 employees in APAC and are well known for multiple product portfolios ranging from capital equipment to consumables. Due to exciting expansion plans and new product launches, the QA/RA team is bringing in a new RA headcount taking care of APAC region.

Responsibilities

Reporting to the RA/QA Manager, you will be part of the regional office and play an important role in coordinating the process for medical device registrations and facilitates complaint reporting.

The Regulatory Affairs Specialist will work alongside the team to coordinate product registration for all new & renewal devices, while ensuring the provision of documents for dossier preparations within specified timeframe. You will also provide regulatory assessment for new products, review documents for post market change notifications, and be up-to-date with regional regulations.

Requirements

The ideal candidate is someone with minimum 2 years of Regulatory Affairs and/or Quality Assurance experience, ideally within the Medical Devices sector. You will need to be meticulous and process driven, while constantly stay updated to regulatory changes in the region. You will also need to be a strong team player, and thrives in a process-driven environment.

Due to nature of the role, you will be required to work from office from Monday to Friday (office hours).

If you would like to be considered for this opportunity, please apply to the advertisement or forward a copy of your full CV to [Confidential Information].

Business Registration Number: 202509847W | Licence Number: 25S2778 | EA Registration Number: R1653095