Regulatory Affairs Projects Manager

The company 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 3 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 fluency in English Manage multiple projects simultaneously

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

GCP certificate - advantage