Regulatory Affairs Specialist

2 weeks ago

Haifa, Haifa, Israel Medtronic Full time ₪60,000 - ₪120,000 per year

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 the
future.

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 worldwide 
  • Write, update and maintain technical files for Class I, IIa and IIb
  • Support global regulatory requirements and submissions
  • Support QMS changes, PMS and CAPA activities related to the regulatory field
  • Responsible for labeling requirements and compliance 

Note: 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 discipline 
  • Minimum of 3 years of related experience 
  • Strong understanding of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR) 
  • Experience with submissions in different territories 
  • Experience in interpreting and applying regulatory guidelines and standards  
  • Excellent attention to detail and organizational skills 
  • Ability to manage multiple projects and deadlines 
  • Effective communication skills to liaise with regulatory agencies and internal teams 
  • Fluent in Hebrew and English (verbal and written communication skills

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  
 

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