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Regulatory Affairs Specialist, Asean

3 weeks ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

Medical Device MNC leading technological innovations specialising in Orthopaedics
- Competitive renumeration
- Regional responsibilities

**JOB DESCRIPTION**

The successful incumbent will be responsible for the daily regulatory affairs operations including regulatory submissions and ensuring the compliance of regulatory affairs matters affecting the company’s operations and products.
- Prepare and submit regulatory documents of products for the ASEAN markets, supporting distributors and the company’s affiliates.
- Liaising with relevant regulatory authorities on submission projects if necessary
- RA planning for ASEAN markets, and supporting APAC level projects when needed
- Review product labelling and directions for use (if translation is required)
- RA compliance and document control, maintaining and updating product registration and listing databases for assigned countries
- Collect and assess product change information to take necessary actions, including regulatory submissions
- Regulatory intelligence
- Recall and complaint support, FSCA, post-market surveillance
- Participate in Quality System Audits (Internal/External)

**Requirements**:

- Relevant Bachelor’s Degree (e.g. Science, Engineering)
- At least 2 - 4 year of Medical Device RA experience
- Strong knowledge and understanding of ASEAN regulations
- Excellent interpersonal skills - Internal and external stakeholders management
- Ability to prioritize and to work in a fast-paced environment handling multiple tasks/requests
- Proactive, independent, and a great team player
- Resourceful and inquisitive, able to comprehend technical/engineering/medical terminology or able to reference literature for better understanding

Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502