Regulatory Affairs Specialist

1 week ago

Yoqneam Illit North District, Israel Medtronic Full time $90,000 - $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 Life
If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we'd love to hear from you. Join us as a Regulatory Affairs Specialist.

Our products include different technologies (active and non-active, hardware, software and AI) and are sold in more than 30 countries.

The Regulatory Affairs Specialist will be part of the Regulatory team at the Yokneam site, reporting to Senior Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in the U.S. and globally.

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

  • Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections
  • Lead or compile materials required for submissions, license renewal, and annual registrations
  • Write, update and maintain technical files for class IIa products
  • Perform Regulatory operations activities, including updating databases and coordination with Medtronic cross functions to release products
  • Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
  • Stay updated on regulatory procedures and changes

Required Knowledge and Experience:

  • Bachelor's degree in scientific discipline
  • Minimum of 2 years' experience in regulatory affairs
  • Experience in the medical device industry
  • 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
  • Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines
  • Fluency in Hebrew and English, both written and verbal, is essential

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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