- Participate in the development and lifecycle of products to ensure compliance with all internal and external requirements for markets such as EU, US and APAC.
- Develop, strategize, drive, implement and maintain regulatory submission plans in order to meet project milestones
- 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 and provides recommendations and assistance to ensure company compliance
- Prepare, update and maintain technical files/submission dossiers as per applicable SOPs, and liaise closely with the relevant departments as required.
- Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks
- Responsible for the Quality strategies, policies, processes, standards and systems for the Company
- Regulate, control and improve quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
- 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.
- Brings QMS/Regulatory Affairs questions/issues to the attention of management to ensure continuous improvement
- Work closely with product development team to support any troubleshooting activities as applicable.
- Bachelor or Master of Science or Biomedical Science related
- Minimum 5 years of Quality system/ Regulatory affairs working experiences in medical device industry.
- Independent and proactive working attitude
- Good command of English (Reading, writing and speaking).
- Understand ISO requirement of MDD, MDR, IVDR, CE, FDA mark or other standard/regulation for medical device and can provide or prepare the related documents.
- Knowledge in Quality Management System, preferably a Certified Internal Auditor
- Understanding of Medical device software development is desired but not required.