Regulatory Affairs Engineer

Eitan Medical is reinventing drug delivery across the continuum of care with connected, software-based solutions from the hospital to the home. We focus on creating user-friendly, innovating patient- centered care and safe solutions; we’re looking for an excellent and experienced Regulatory Affairs Engineer to join our great team. You will join a dynamic and fast-paced environment and work with a team of talents to build and roll-out cutting-edge products that deliver the company’s innovative vision and strategy.

Job Description:

• You will Support the process of adverse events reporting to various countries worldwide

• You will Communicate with worldwide authorities

• As a Regulatory Affairs Engineer you will Conduct RA strategy and evaluation of: (i) design changes, (ii) Materials non conformities and (iii) investigations

• Field action/Recalls execution

• Leading Post Market Surveillance activities

• Participating and supporting in additional cross-department tasks

Direct manager: Regulatory Affairs Director

Experience: Minimum of 1 year experience as a quality/regulatory specialist

· Education: Bachelor's degree in a scientific discipline or equivalent

· Language skills: English - Mother tongue level

· Computer skills: full control in Office, SAP - advantage

· Other:

o Availability for intensive work, including unconventional hours when required

o Ability to work under pressure and in tight schedules

o Strategic thinking from planning to execution and follow up for regulatory and quality.