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Regulatory Affairs Specialist - Spine

Regulatory Affairs
190003S4 Requisition #
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Regulatory Affairs Specialist - Spine Products

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


• Develop global regulatory strategies for medical device product submissions.
• Participate as the regulatory representative on teams, providing regulatory strategy, timelines, and direction.
• Assess documentation for compliance with regulatory requirements.
• Assist in keeping company informed of global regulatory requirements.
• Organize, prepare, and post international submissions and supporting documents.  Work with regional counterparts to obtain product approvals and product renewals.
• Review product changes in collaboration with the other specialists and assess regulatory impact of product changes on domestic and international markets. Provide documentation to geographies that require a submission or amendment.
• Support review of labeling, training, promotional and advertising material.
• Support post market regulatory compliance activities for global product approvals.
• Develop and maintain regulatory affairs department procedures.
• Comply with applicable global regulatory laws/standards and Company policies and procedures.
• Work within the department and cross-functionally to resolve potential regulatory issues and questions from regulatory agencies or internal sources.
• Keeps abreast of regulatory procedures and changes
• May direct interaction with regulatory agencies on defined matters. 


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
• Bachelor’s degree in Engineering, Life Sciences, or related medical/ scientific field
• 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
Preferred Experience:
• Experience with US / International medical device regulatory submissions (including 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
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.
• 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:
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.

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.
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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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