Benefit and Highlights:
- Great Place to Work Certified
- Attractive Employee Benefits
- Location : Buona Vista
- Reporting : Regulatory Affairs Manager, APAC
Main Objective:
Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.
Essential Duties and Responsibilities:
1. Submissions & Applications
- Prepare, write, and submit regulatory documents for SEA markets (distributors & subsidiaries).
- Communicate with regulators and manage multiple submission projects.
- Participate in regulatory planning for SEA and support APAC-level projects.
- Review product labeling and DFU translations.
2. Compliance & Document Control
- Maintain regulatory data (licenses, dossiers, change info) in RIMS and other systems.
- Evaluate product changes for compliance and communicate impacts to stakeholders.
3. Education & Regulatory Intelligence
- Attend seminars and conferences for continuous learning.
- Monitor SEA regulatory updates and support global change management projects.
- Collaborate cross-functionally on new product and country launches.
4. Product Safety & Post-Market Support
- Assist with product recalls, safety alerts, and field actions.
- Support post-market surveillance (complaints, PER, AER) and liaise with regulators.
- Participate in internal and external quality audits.
Education and Experience:
- Degree qualified preferably in an Engineering or Science discipline
- Minimum 2-3 years direct RA experience within a medical device company
Knowledge and Skill Requirements/Specialised Courses and/or Training:
- Strong understanding of medical device regulations and standards across the SEA region.
- Familiarity with global regulatory frameworks is an added advantage.
- Exceptional interpersonal and communication skills, with the ability to build and maintain strong relationships with stakeholders at all levels.
- Proven ability to work independently as well as collaboratively within a team environment.
- Skilled in managing multiple priorities and delivering results in a dynamic, fast-paced setting.
- Ability to comprehend technical, engineering, or medical terminology and reference relevant literature for clarity.
- Technical expertise in manufacturing or design related to regulatory affairs is considered advantageous.
Interested applicants are to apply online with us!
