Regulatory Affairs Specialist

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remote type Remote

locations Virtual, Tel Aviv District, Israel

time type Full time

posted on Posted Today

job requisition id R-801450

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About The Role

An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Responsibilities may include the following and other duties may be assigned:

• Prepare, coordinate, and compile regulatory submission packages (e.g., registrations, renewals, design change submissions) to ensure timely approvals in Israel and potential other countries.
• Lead or support activities required for annual registrations and license renewals.
• Collaborate with regional post-market and quality teams to ensure compliant execution of vigilance requirements and post-market regulatory obligations.
• Lead and support activities required for Regulatory Clinical submissions
• Review promotional materials, labelling, and product claims for regulatory accuracy and compliance.
• Engage directly with regulatory authorities on defined matters, supporting queries, data requests, and remediation activities.
• Recommend regulatory strategies to support the earliest possible approval .
• Monitor regulatory trends and support MiniMed readiness for evolving requirements in Israel.
  
  

Required Knowledge And Experience

• Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
• 2-5 years of medical device regulatory experience (depending on level) tied to Israeli submissions and processes, with strong knowledge of Israeli regulation
• Proficiency in Hebrew and English
• Experience with Israeli registration processes, technical documentation preparation, interaction with Ministry of Health, as well as product release licensing procedures, post-market surveillance, Field Safety Corrective Actions (FSCA) support, while also possessing expertise in hosting or supporting regulatory audits
  
  

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

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.