This is a great opportunity for early career RA professionals seeking regional responsibilities and working alongside a high-performing and passionate regulatory team.
- Portfolio: Surgical/Implantables
- Region: APAC
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 APAC markets, supporting distributors and the company’s affiliates.
- Liaising with relevant regulatory authorities on submission projects if necessary
- RA planning for APAC 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 years of Medical Device RA experience
- Strong knowledge and understanding of ASEAN/Asia/APAC 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
Candidates who demonstrate greater depth of experience may be considered for a senior title (i.e. Senior RA Executive).
Interested applications may apply with your most recent CV in word format, and we will connect shortly for a confidential discussion on this amazing opportunity.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
