Principal Regulatory Affairs Specialist- Yokneam

Must Have: Minimum Requirements

Education:

• Science degree

Experience:

• Minimum of At least 5 years relevant experience  (based on the above)

• Knowledge of US and international medical device regulatory requirements. Experience with FDA submissions (510k) is mandatory.

• Experience with Class II devices is a plus

Skills:

• Autonomy: be recognized expert in regulatory arena, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.

• Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. You may manage large projects or processes that span outside of immediate job area.

• Innovation and Complexity: Develops solutions to moderately complex problems, and/or makes moderate to significant.

• Improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.

• Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.

• High level experience with Microsoft Office Suite, SAP experience is a plus

• The role requires the job holder to have a professional and proactive work ethic and work well within a team dynamic

• Excellent English level (speaking, writing)

• Excellent writing skills, experience with writing rationales, submissions and regulatory evaluations.

• Administrative and organizational skills
  
  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.
  
  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.
  
  The physical demands described within the Day in the Life 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.