Senior Regulatory Affairs Specialist

Must Have (Minimum Requirements):

 Bachelor’s degree

• Bachelor's degree and 4+ years of experience in regulatory affairs in the medical device industry,  OR advanced degree and 2+ years of experience in regulatory affairs in the medical device industry.  

Nice to Have (Preferred Qualifications):

•  4+ years medical device industry experience.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• New product development experience
• IVD experience
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient computer skills. 
• Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.
• Experience performing advertising and promotion reviews for medical devices.
• Experience with FDA and international regulatory agency requirements
• Project management skills.
• Excellent oral and written skills.
• Excellent analytical thinking skills.

Physical job 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 by phone and in-person with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites or FDA locations.
• Must be able to travel by plane and by car.(<10%) 

ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.