Nitto Denko Asia Technical Centre Pte. Ltd.| Date Posted: 1-Aug-2020
Bachelor's / Honours
- Collects documentation and coordinates with cross-functional teams to prepare regulatory submissions to regulatory agencies (or commercial partners).
- Creates and maintains regulatory submission timelines and track deliverables to ensure company goals are met.
- Supports overall organizational regulatory strategies
- Provides strategic input and regulatory advice to project teams on development programs including new product development and changes to existing products.
- Keeps abreast of current regulatory landscape for medical device globally, e.g., FDA guidance documents, Medical Device Regulations (MDR), EU guidance documents, IEC 62304, ISO 13485.
- Develops and communicates recommendations regarding new/emerging regulations to management and project teams.
- Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks.
- Reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
- Support QMS team in development of procedures, other quality documentations as applicable.
- To translate new and complementary standards’ requirements into documents (QM, SOPs, Forms) and define the applicability of the requirements for the different types of businesses. E.g., EU IVDR, GDPMD, IEC 62304 and etc.
- Support process improvement for Regulatory Affairs function
- Monitors FDA, HSA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance
- Brings QMS/Regulatory Affairs questions/issues to the attention of management
- Work closely with product development team to support any troubleshooting activities as applicable.
- Preferred Degree in Chemical Engineering, Chemistry, Biomedical Science.
- At least 3 years prior experience in medical device industry is preferred.
- Understanding of Medical device software development is desired.
Interested applicants, please apply via the "Apply Now" button with your updated CV. Kindly include current salary, expected salary and notice period.
We regret that only shortlisted candidates will be notified.
Nitto Denko Asia Technical Centre Pte. Ltd.