Regulatory Affairs Specialist, Asia (Medical Devices)

• Well-established and stable Medical Devices manufacturer
• Regional coverage across Asia
• Base salary up to $4,500/month + AWS + Bonus

We are working with an Asian-based Medical 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 therapeutic areas ranging from capital equipment to consumables & implants.

Responsibilities

Reporting to the RA/QA Manager, you will be part of the regional office and plays an important role in coordinating the process for medical device registrations and market access approvals. You will assist in reviewing and approving of documents to support Post Market Change notifications and be up-to-date with new regulatory updates. On the QA front, you will manage all complaint handling from subsidiary offices and to follow up with investigations with the manufacturing plants.

Requirements

The ideal candidate is someone with 1 - 3 years of Regulatory Affairs experience, ideally within the Medical Devices sector. Having some regional (SEA) experience will be an added advantage. You will need to be meticulous and process driven, while constantly stay updated to regulatory changes in the region.

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

If you would like to be considered for this opportunity, please forward a copy of your full CV to Richard.Tey@ambition.com.sg.

Data provided is for recruitment purposes only. Only shortlisted candidates will be notified.

Business Registration Number: 200611680D | Licence Number: 10C5117 | EA Registration Number: R1653095

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