Medtronic
Regulatory Affairs Specialist - Spine (Finance)
Careers That Change Lives
The Regulatory Affairs Specialist (RAS) will coordinate, author, prepare, and update technical document packages for domestic and international spinal medical device regulatory submissions, including 510(k)s and technical files, for new and existing products according to regulatory requirements and standards. You will interact with cross-functional counterparts, including engineers, microbiologists, and others. This role is responsible for communicating regulatory requirements for new and existing products to cross-functional partners, and review documentation for compliance. You will ensure regulatory compliance through the design process for new products, conduct regulatory assessments for, and author regulatory documentation to support changes to product design, labeling, packaging, or manufacturing process.
A Day In the Life
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Medtronic is a world leader in spinal and musculoskeletal therapies. The Spine & Orthopedic Therapies Group provides spinal fusion and artificial disc products from Medtronic, including bone graft options and minimally invasive spinal surgery options for patients.
Come for a job. Stay for a career.
Must Have: Minimum Requirements
Preferred Experience:
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.
Spine & Orthopedic Therapies Group:
Medtronic is a world leader in spinal and musculoskeletal therapies. The Spine & Orthopedic Therapies Group provides spinal fusion and artificial disc products from Medtronic, including bone graft options and minimally invasive spinal surgery options for patients.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career.
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.
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.
Come for a job. Stay for a career.