At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life Medtronic At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease.
This position will reside in the Peripheral Vascular Health organization that cares for millions of patients globally with life-enhancing therapies.
The Regulatory Affairs Specialist is responsible for worldwide regulatory activities to introduce new products (Class II and Class III) to global market, maintain existing products and provide advice on regulatory requirements.
The Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes.
This role focuses on a wide variety of regulatory tasks to allow the Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set daily working within a collaborative team environment.
The Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.
A Day in The Life Of: Responsibilities may include the following and other duties may be assigned.
Team with Operating Unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for market expansion of new products/therapies.
Lead or compile all materials required in submissions, license renewal and annual registrations.
Work with engineers and technical experts to address questions from regulatory agencies.
Provide support to currently marketed products as necessary.
This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review.
Prepare submissions and reports for FDA or provide support and documentation for international submissions.
Maintain proficiency in worldwide regulatory requirements.
Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through verbal and written communications.
May assist in negotiations with the FDA or other regulatory agencies for defined projects.
Other tasks, as assigned.
Key Skills