Regulatory Affairs Specialist - RTG Neurovascular
The Restorative Therapies Group (RTG) 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.Brain Therapies offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
Careers That Change Lives
The Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for contributing to the regulatory global strategy, review of design changes, manufacturing changes and specification changes.
· Participate on project teams, providing regulatory strategy, timelines, and deliverables
· Prepare US and EU submissions. Work with FDA, Notified Body, and regulatory geography support to obtain product approval/clearance.
· Develop US and International regulatory strategies and timelines for product submissions; identifying needs for bench, animal and clinical testing
· Review Change Orders and assess regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures
· Review labeling and assess compliance against relevant regulations and product requirements
· Develop and maintain regulatory affairs department procedures and process improvements Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
· Assist in keeping company informed of regulatory requirements in the US and EU.
Must Have: Minimum Requirements (Must be evident on the resume or cover letter)
- Bachelor’s Degree
- Minimum two years regulatory affairs experience with medical devices or 0 years of experience with an advanced degree
Nice To Have
- 510(k) or PMA submission experience
- Regulatory Affairs Certification
About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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. 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. For Office Roles: 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. 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)
Change Begins With You
We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.
The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.
Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.
Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.
Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.
“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.”
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.
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