International Regulatory Affairs Specialist

Basic Qualifications

• Bachelors Degree in health profession, science and/or engineering field, 
• Minimum two years in the medical device industry

Desired/Preferred Qualifications
 

• Regulatory Affairs experience with international submissions
• Understanding of engineering concepts, medical device development, anatomy, and medical practice
• Experience working with technical documentation
• Advanced degree in Regulatory Affairs
• Strong communication skills (written and verbal)
• Proven success managing multiple projects and priorities
• Attention to detail
• Advanced analytical thinking skills
• Ability to work with various cultures and personality types; enjoy working in team environment
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
• Ability to manage small scale projects to completion within and outside of the direct department.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within in the regulatory landscape.
• Ability for flexible work schedule due to interaction with colleagues in different time zones (must be able to attend early morning and late evening meetings)
• Proficient in Microsoft Word, Excel, and PowerPoint

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 Position 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is required to be independently mobile

• The employee must be able to travel independently to various Medtronic buildings/sites.

• The employee is required to interact with a computer, and communicate with co-workers

• The employee is required to travel by car and by airplane (<20%)

EEO STATEMENT:

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

DISCLAIMER:

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.