Regulatory Affairs Specialist

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
• Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field.

Years of Experience:
• 2+ years w/ Bachelor’s degree or 0+ years w/Master’s degree experience in Regulatory Affairs, Engineering, Quality or related Technical field.

 Specialized Knowledge Required:

DESIRED/PREFERRED QUALIFICATIONS:
• Working knowledge of global medical device regulations, including submissions. 
• Demonstrated writing/technical writing skills.
• Demonstrated Microsoft Word, Excel and Adobe software skills.

• Experience in or exposure to combination devices.
• Experience in or exposure to pharmaceutical regulations.
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Effective verbal and written communication skills.
• Effective organizational skills.
• Experience with solving problems and concerns.
• Attention to detail.
• Effective negotiating skills.
• Experience with project management and adherence to time schedules.
• Quality or Regulatory compliance experience or background.
• Self-motived
• Work well under pressure in a dynamic environment.
• Ability to audit own work to ensure compliance.

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.