Company Overview:
Join a pioneering genetic testing company at the forefront of precision medicine with a unique ability to build products based on the Asian genome to develop landmark products and provide highly accurate results, even in diverse populations. Our mission is to revolutionize healthcare through innovative genetic testing solutions. We're committed to advancing personalized medicine and improving patient outcomes through cutting-edge technology and scientific research
Position Overview:
We are looking for a detail-oriented professional to lead our Quality Assurance (QA) and Regulatory Affairs (RA) functions, ensuring compliance with ISO13485 and regulatory requirements for medical device distribution. This role involves managing company licenses, overseeing regulatory submissions, maintaining the document control system, leading audits and investigations, handling non-conformances (NCs), and ensuring effective supplier qualifications and field safety corrective actions (FSCAs). The ideal candidate will have experience in QA, RA, and regulatory compliance, with CDAKB certification preferred.
Responsibilities:
- Responsible for maintaining information security.
- Ensure company’s ISO13485:2016 Quality Management System is carried out effectively and maintained in accordance to released quality procedures, work instructions, documentation control system and applicable statutory and regulatory requirements.
- Implement and communicate company’s Quality Policy and Quality Objectives throughout the organization.
- Review complaint investigations.
- Act as the Technical Person in Charge (PJT) and manage company licenses for medical device distribution (IDAK & CDAKB). Having CDAKB certification will be preferable.
- Provide lead for quality assurance and regulatory affairs tasks for inter/intra-company transfers of new technology, products, processes and methods.
- Review supplier qualifications for determination of supplier status (critical supplier vs non-critical supplier, accept vs reject, etc).
- Handling of product and process NCs including but not limited to investigation, CAPA and disposition of affected products.
- Reporting the flow of distribution, destruction, and adverse event/recall of medical devices to the authorized body.
- Trend and report Quality systems related information (deviations, investigations CAPAs, etc.), and prepare and compile statistical quality data for updates and project status reports on site’s quality performance in Management Review Meeting.
- Create and maintain internal audit (IQA) and external audit schedules, and records including tracking CAPA activities as required.
- Conduct audits (Internal, Vendors, Suppliers) as necessary.
- Activation of Field Safety Corrective Actions (FSCAs), product recall, regulatory authority notifications and any follow up actions needed as and when required.
- Management of document control system, including periodic review of procedures.
- Determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
- Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
- Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
- Any other duties assigned by the CEO/COO from time to time
Job Qualifications:
- 3 – 4 year(s) of working experiences as Quality Assurance and/or Regulatory Affairs in healthcare business (preference on Medical device or diagnostic industry).
- Bachelor of Pharmacy with pharmacist certification.
- Highly knowledgeable about medical device registration systems including but not limited to OSS, Regalkes, KFA, E-catalogue, etc.
- Having CDAKB Certification is required.
Join our team and help shape the future of personalized medicine! If you are passionate about making a difference and thrive in a dynamic, entrepreneurial environment, we want to hear from you. Apply now to be part of our growing company!
Company Overview:
Join a pioneering genetic testing company at the forefront of precision medicine with a unique ability to build products based on the Asian genome to develop landmark products and provide highly accurate results, even in diverse populations. Our mission is to revolutionize healthcare through innovative genetic testing solutions. We're committed to advancing personalized medicine and improving patient outcomes through cutting-edge technology and scientific research
Position Overview:
We are looking for a detail-oriented professional to lead our Quality Assurance (QA) and Regulatory Affairs (RA) functions, ensuring compliance with ISO13485 and regulatory requirements for medical device distribution. This role involves managing company licenses, overseeing regulatory submissions, maintaining the document control system, leading audits and investigations, handling non-conformances (NCs), and ensuring effective supplier qualifications and field safety corrective actions (FSCAs). The ideal candidate will have experience in QA, RA, and regulatory compliance, with CDAKB certification preferred.
Responsibilities:
- Responsible for maintaining information security.
- Ensure company’s ISO13485:2016 Quality Management System is carried out effectively and maintained in accordance to released quality procedures, work instructions, documentation control system and applicable statutory and regulatory requirements.
- Implement and communicate company’s Quality Policy and Quality Objectives throughout the organization.
- Review complaint investigations.
- Act as the Technical Person in Charge (PJT) and manage company licenses for medical device distribution (IDAK & CDAKB). Having CDAKB certification will be preferable.
- Provide lead for quality assurance and regulatory affairs tasks for inter/intra-company transfers of new technology, products, processes and methods.
- Review supplier qualifications for determination of supplier status (critical supplier vs non-critical supplier, accept vs reject, etc).
- Handling of product and process NCs including but not limited to investigation, CAPA and disposition of affected products.
- Reporting the flow of distribution, destruction, and adverse event/recall of medical devices to the authorized body.
- Trend and report Quality systems related information (deviations, investigations CAPAs, etc.), and prepare and compile statistical quality data for updates and project status reports on site’s quality performance in Management Review Meeting.
- Create and maintain internal audit (IQA) and external audit schedules, and records including tracking CAPA activities as required.
- Conduct audits (Internal, Vendors, Suppliers) as necessary.
- Activation of Field Safety Corrective Actions (FSCAs), product recall, regulatory authority notifications and any follow up actions needed as and when required.
- Management of document control system, including periodic review of procedures.
- Determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
- Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
- Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
- Any other duties assigned by the CEO/COO from time to time
Job Qualifications:
- 3 – 4 year(s) of working experiences as Quality Assurance and/or Regulatory Affairs in healthcare business (preference on Medical device or diagnostic industry).
- Bachelor of Pharmacy with pharmacist certification.
- Highly knowledgeable about medical device registration systems including but not limited to OSS, Regalkes, KFA, E-catalogue, etc.
- Having CDAKB Certification is required.
Join our team and help shape the future of personalized medicine! If you are passionate about making a difference and thrive in a dynamic, entrepreneurial environment, we want to hear from you. Apply now to be part of our growing company!