Regional Regulatory Affairs Specialist (Medical Device)

We are working with a fast-growing Asian based medical devices company, and they are expanding rapidly across the region. Due to their growth, they are looking to expand the RA function to support the RA Director in any applicable regulatory and quality requirements.

Responsibilities

1. Reporting to the Regional Regulatory Affairs Director, you will play an important role in supporting the regulatory strategy execution for new product registrations, license amendments, and relevant renewals.
2. You will also maintain strict regulatory compliance in the region to maintain the company's competitive advantage.
3. As the company is scaling up, you will also get the opportunity to bring products globally and define the regulatory framework for the organisation.

Requirements

1. The ideal candidate is someone with 5 years of Regulatory Affairs experience within the Medical Devices industry, ideally in medical consumables.
2. Having a good understanding of RA requirements in Asia / SEA will be needed.
3. You may also be required to travel regionally, up to 20%.
4. You will need to be meticulous and able to display strong critical thinking and decision making capability.

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