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Senior Regulatory Affairs Specialist

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Regulatory Affairs
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190000VW Requisition #
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Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.

Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.


A Day in the Life

As part of your day to day as a Senior Regulatory Affairs Specialist at Medtronic Yoqneam you will:

  • Prepare and lead submissions to FDA (510k, pre-submission packages, additional information requests).
  • Lead moderate international submissions
  • Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company (collaborates with R&D, Engineering and other departments as needed).
  • provide regulatory guidance for product’s requirements.
  • Support internal/external audits and inspections.
  • Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.



Must Haves

  • Scientific degree
  • Minimum of At least 4 years relevant experience (based on the above)
  • Knowledge of US and international medical device regulatory requirements

Nice to Haves

  • Experience with Class II devices

 

Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button!

About Medtronic
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.

PHYSICAL REQUIREMENTS

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.


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