On behalf of our global partner operating in the medical device sector, we are looking for a"Regulatory Affairs Quality Assurance Specialist" to join their growing team.
Support the preparation, compilation, and submission of regulatory applications (new, existing, and variation) to obtain and maintain product registrations inÜTS,
...
Manage distributor registrations and updates within the ÜTS platform,
Manage reimbursement applications and processes in line with SUT requirements,
Monitor regulatory developments from local and international authorities; proactively communicate relevant updates to internal stakeholders and support the timely implementation of required actions.
Handle product complaints in accordance with company procedures and Ministry of Health requirements (EBS system), ensuring timely reporting and follow-up,
Ensure all product complaint investigations are conducted thoroughly, with comprehensive investigation reports delivered to customers within defined timelines,
Communicate effectively with external stakeholders, including regulatory authorities, notified bodies, and industry partners, ensuring compliance and alignment,
Collaborate and maintain close alignment with the RA Department at Global HQ.
Ensure strict compliance in warehouse and logistics operations, including proper storage conditions, handling, and distribution of medical devices,
Monitor and control warehouse quality processes, including temperature/humidity tracking and documentation accuracy to ensure product integrity,
Support internal, external, and regulatory/official audits.
show more
On behalf of our global partner operating in the medical device sector, we are looking for a"Regulatory Affairs Quality Assurance Specialist" to join their growing team.
Support the preparation, compilation, and submission of regulatory applications (new, existing, and variation) to obtain and maintain product registrations inÜTS,
Manage distributor registrations and updates within the ÜTS platform,
Manage reimbursement applications and processes in line with SUT requirements,
Monitor regulatory developments from local and international authorities; proactively communicate relevant updates to internal stakeholders and support the timely implementation of required actions.
Handle product complaints in accordance with company procedures and Ministry of Health requirements (EBS system), ensuring timely reporting and follow-up,
Ensure all product complaint investigations are conducted thoroughly, with comprehensive investigation reports delivered to customers within defined timelines,
Communicate effectively with external stakeholders, including regulatory authorities, notified bodies, and industry partners, ensuring compliance and alignment,
...
Collaborate and maintain close alignment with the RA Department at Global HQ.
Ensure strict compliance in warehouse and logistics operations, including proper storage conditions, handling, and distribution of medical devices,
Monitor and control warehouse quality processes, including temperature/humidity tracking and documentation accuracy to ensure product integrity,
Support internal, external, and regulatory/official audits.
show more