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

Mazor 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 the future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
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.

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

• Lead regulatory impact assessments for design, manufacturing, labeling, packaging, and supply chain changes. 
• Provide regulatory input to changes as part of the product lifecycle activities. 
• Support and maintain international registrations, renewals, and change notifications across global markets. 
• Lead regulatory review of labeling and identification changes, including deviations. 
• Serve as a regulatory focal point for operations, distribution, and Global Trade Services (GTS). 
• Provide regulatory support for QMS changes and post market activities (including PMS and CAPA). 
• Collaborate cross functionally with Quality, Manufacturing, Supply Chain, and Global RA to resolve regulatory issues. 
• Prepare and maintain accurate, regulatory documentation (Technical Documentation) in controlled systems.

Required Knowledge and Experience:

• Bachelor’s degree in engineering, life sciences, or a related scientific discipline. 
• 3+ years of experience in medical device regulatory affairs. 
• Strong working knowledge of FDA and EU (MDD/MDR) medical device regulations. 
• Proven experience supporting international registrations, labeling, change management, and post market activities. 
• Demonstrated ability to operate independently, apply sound regulatory judgment, and manage multiple complex topics in parallel. 
• Fluent in English and Hebrew (written and verbal).

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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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