Regulatory Affairs Specialist - Spine
• 2+ years of medical device experience with experience in regulatory affairs with a Bachelor's degree/ 6+ months of medical device experience with experience in regulatory affairs with a Master's degree
• Experience with 510(k) submissions
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing technical and design specifications
• Experience in medical device industry
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Documented evidence of writing skills
• Basic understanding of computer applications
• Familiarity with medical terminology a plus
• Some overnight travel required
• The employee is regularly required to be independently mobile.
• The employee is required to interact with a computer, and communicate with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.
Spine & Orthopedic Therapies Group:
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
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.
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.