We are looking for a teammate to take part in our Tender and Regulation Team.
Job Responsibilities
· Develop close collaboration and communication with global manufacturers to keep up to date on the product documents and in-depth understanding of local regulatory requirements.
· Coordinate and prepare document packages for regulatory submissions for respective operating units.
· Review and keep organized the requirements of the UTS and all other portals that Turkish MoH use.
· Ensure effective follow-up of submissions and timely approvals.
· Review document change requests which may impact existing or ongoing registrations and product supply.
· Keep abreast of regulatory procedures and changes.
· Direct interaction with regulatory agencies on defined matters.
· Coordinating the communication and RA activities between the departments, RA platforms and business.
· Communicate with all might-related authorities to gather tender documents and prepare tender documents within defined deadlines.
· Ensure the smooth process for both the pre-contract and after-contract stages.
Qualifications / Skills
· Bachelor’s degree
· 3-4 years’ work experience
· Having medical device experience is a plus.
· Have a good command of written and spoken English
· Have good organization skills
· Good detail-capturing skills while working in a fast-moving environment.
· Be computer literate (Word, Excel, PowerPoint, INTERNET, etc.)