Principal Regulatory Affairs Specialist

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
• BA/BS/MS/Law degree
• 5 years or more of experience in regulatory affairs or FDA experience

DESIRED/PREFERRED QUALIFICATIONS:

• Experience with internet/intranet technology and interactive software applications
• Competency with Microsoft Office applications and Adobe Acrobat
• Seasoned professional with significant experience with FDA requirements, guidance documents, 510(k) submissions, EU Medical Device Directive/Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• History of successful global device submissions
• Through knowledge of GCP/GLP requirements
• Recognized expertise in one or more areas of regulatory
• Significant knowledge of other cross functions and business acumen.  Expert problem solving skills and experience with complex issues that require resolution.  Ability to work independently and make decisions that have significant impact to the company.  Experience with interacting and building relationships with regulatory agencies
• Knowledge of clinical study requirements
• Excellent negotiation skills and written/oral communication skills
• Demonstrated organizational , time management, and project management skills
• Self-motivated.  Acts on own initiative to identify opportunities and propose solutions outside the scope of their job responsibility

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.

MEDTRONIC OVERVIEW:
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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.  In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:  http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.