Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMazor Robotics, Ltd., a Medtronic company.Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape thefuture.The Regulatory Affairs Specialist will be part of the Regulatory team at the Caesarea site, reporting to Regulatory Affairs Manager, supporting ongoing activities as required. The individual will serve as Regulatory Affairs representative in various workstreams.Responsibilities may include the following and other duties may be assigned:Regulatory assessments and registrations worldwideWrite, update and maintain technical files for Class I, IIa and IIbSupport global regulatory requirements and submissionsSupport QMS changes, PMS and CAPA activities related to the regulatory fieldResponsible for labeling requirements and complianceNote: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.Required Knowledge and Experience:A Bachler's degree in related scientific or engineering disciplineMinimum of 3 years of related experienceStrong understanding of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR)Experience with submissions in different territoriesExperience in interpreting and applying regulatory guidelines and standardsExcellent attention to detail and organizational skillsAbility to manage multiple projects and deadlinesEffective communication skills to liaise with regulatory agencies and internal teamsFluent in Hebrew and English (verbal and written communication skillsPhysical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.