Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs Manager (Southeast Asia) to join their team in Singapore.
Responsibilities
- Responsible for regulatory activities across Southeast Asia - regulatory submissions, compliance for new or existing products
- Support ANZ RA team on regulatory related activities for their region
- Manage registration plans for new products, variations, modifications, registration renewals
- Analyse registration complexity and provide regulatory advice to internal groups to support company’s business objectives
- Collect and analyse regulatory intelligence, and incorporate regulatory trends into decision-making processes
- Approval of product labelling with local regulations
- Maintain awareness of regulatory requirements or changes
- Provide post market regulatory support and guidance as required
- Follow up on product license renewal
- Any other ad-hoc duties as assigned
Requirements
- Degree in Life Sciences, Engineering, or related discipline
- At least 5 year of related working experience, preferably in the medical device industry
- Possess good knowledge of regulations and requirements for medical devices, GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/ Regulation, US FDA guidance, ISO standards (13485, 9001)
- Knowledge and specialization in Regulatory and Quality Affairs (Quality Control/Assurance) is an advantage
- Excellent communication skills and English at work proficiency level (writing and conversational)
- Proficient in Microsoft Office
- Independent, meticulous, detail-oriented, and proactive
- Ability to Multi-task & Proactive
- Positive working attitude with passion to learn and develop
- Able to adapt in a fast-paced environment
For more information, please apply with a word format CV .
Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502
