RegDesk is a leading AI-enabled regulatory information management software (RIMS) for medical device and diagnostic companies. It allows regulatory affairs teams to prepare, manage, and publish international submissions and gain approval within unprecedented timelines. We offer our services globally and have clients from different countries worldwide.
About you:
If you are a regulatory affairs nerd, self-driven, resourceful, and have attention to detail, then we want to hear from you.
Summary:
We have an immediate opportunity available for a Consultant for Kyrgyzstan, Kazakhstan and Turkmenistan.
PLEASE SUBMIT YOUR CV/RESUME IN ENGLISH ONLY.
Responsibilities:
- Research Ministry of Health websites for regulatory updates, major notifications, or changes daily
- Provide the date, link, and a brief summary of the updates to the Company by the end of the day.
- Additionally, provide specific guidance documents/information on medical devices and IVDs as per the Company's needs. eg. (change assessment guidance, registration template, etc.)
- If there are any significant updates or notifications then the Company may ask the Consultant to provide further assistance to better understand the regulation.
- Provide a montly summary export to Team Leader.
Requirements:
- Bachelors degree or higher in science, preferably Regulatory affairs or Biomedical engineering.
- 7 to 10 years in the medical devices/IVD industries.
- Expert knowledge of Medical device/IVD laws/guidances.
- Hands on experience with device submissions to the health authority.
- Experience communicating with the health authorities.
- Experience dealing with medical devices/IVD changes along with the corresponding registration procedure.
- English level: Advanced.
We provide flexible location and flexible working hours.