Herzliya, ISR
2 days ago
Associate 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 Life** Join our Regulatory Affairs team As an Associate Regulatory Affairs Specialist and be part of a purpose-driven community that is dedicated to improving patient care through high-quality, accessible, and affordable healthcare. As an Associate Regulatory Affairs Specialist, you will play a key role in ensuring that Medtronic’s Pre-market regulatory activities in Israel align with both local Ministry of Health (AMAR) regulations and internal Medtronic standards. You’ll manage submissions, compliance tasks, and regulatory communications with a proactive, timely, and quality-focused approach. You will work closely with global regulatory teams, operation units, and local stakeholders to bring life-changing technologies to patients in need, while maintaining the highest standards of safety and compliance. This is a one-year contract position. **Responsibilities may include the following and other duties may be assigned:** + Manage Pre-market activities, including submissions of new products, renewal and changes to the Israel Ministry of Health (Amar), in a timely and organized manner. + Provide strategic input from regulatory planning through to execution and follow-up of submissions. + Maintain Regulatory and technical documentation of the registered products required by the Israel Medical Device Law and MOH guidelines. + Support change submission processes, including preparation and tracking of the relevant medical device changes. + Perform Regulatory Operations activities, including coordination with Medtronic’s Global Trade Services (GTS) to release blocked orders and control product distribution in accordance with Distribution Control Compliance requirements. This includes ensuring compliance with legal regulations related to import/export, regulatory approvals, and quality standards. + Collaborate with global regulatory affairs teams and operation units to gather and analyze required information + Participate actively in cross-functional teams to meet timelines, resolve regulatory issues, and improve work processes. **Required Knowledge and Experience:** + Bachelor’s degree in scientific discipline + Minimum of 2 years’ experience in regulatory affairs or quality assurance + Full professional proficiency in Hebrew and English + Experience in the medical device industry + Familiarity with local regulatory authorities and submission processes (e.g., AMAR) + Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation) + Excellent attention to details, proactive approach and ability to work independently + High learning agility and ability to work under pressure + Strategic thinking and ownership of regulatory and quality initiatives **Physical Job Requirements** The 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 & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A 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 Medtronic** We 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. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) We 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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