Regulatory Affairs (RA) Projects Manager

Tingo Medical, a Modiin-based medical device startup, operates in the diabetes field. Tingo is developing an innovative automated insulin delivery (AID) system that combines an insulin pump, continuous glucose monitor, and a glycemic control algorithm.

Tingo is looking for a Regulatory Affairs (RA) Projects Manager with experience in submissions (pre-submissions, IDEs, 510(k), PMAs) and in pre-clinical and clinical studies. The RA Projects Manager will report to the head of RA, QA and Clinical Affairs.

Responsibilities

·        Prepare and submit regulatory documentation, including pre-submissions and submission of studies to ethics committees

·        Involved the end-to-end process of pre-clinical and clinical studies planning, including identifying needs, drafting protocols, and overseeing study execution

·        Collaborate with cross-functional teams to oversee product quality and regulatory compliance

·        ⁠Ensure compliance with regulatory standards (e.g., FDA, ISO)

·        Monitor project progress and identify risks

Qualifications

·        ⁠More than 5 years of experience in medical device industry, with familiarity in ISO 13485 and FDA QSR 820 - a must

·        Bachelor's degree in engineering or a related scientific field – a must

·        Experience in preparing regulatory submissions (FDA and international submissions)– a must

·        ⁠Proven project management abilities

Skills / Attributes

·        Proven fluency in English Manage multiple projects simultaneously

·        ⁠Strong communication and interpersonal skills

·        ⁠Ability to collaborate effectively with cross-functional teams (R&D, quality, clinical), subcontractors, and KOLs

·        Self-starter with the ability to learn independently

·        Ability to work in a fast- paced and dynamic environment

·        ⁠Training experience in clinical/ technical environment – advantage

·        GCP certificate - advantage

Full time job.

Resume to be sent to: [email protected]