Medtronic
Healthcare
RegulatoryAffairsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Medical devices, Global regulatory requirements. Lead submissions compilation. Compile license renewal materials”
Industry & Context.
What They're Looking For.
Must Have
NFQ Level 8 Bachelor’s degree, 2 years relevant experience, Master’s degree no experience
Nice to Have
Experience with Class II/III devices, Experience with FDA requirements, Experience with MDD, Experience with MDR, Experience with medicinal consultations, Experience with global regulatory requirements, Experience with quality standards
What You'll Do.
Lead submissions compilation
Compile license renewal materials
Compile annual registrations materials
Address agency questions
Provide support to marketed products
Review labeling changes
Review product changes
Review process changes
Prepare FDA submissions
Provide international submission support
Maintain worldwide regulatory requirements proficiency
Establish RA department relationships
Establish cross-functional team relationships
Develop positive reviewer relationships
Assist in FDA negotiations
Assist in agency negotiations
How You'll Work.
Team & Collaboration
Cross-functional teams; RA department; Device reviewers
Communication Scope
Written communication; Verbal communication
Full Job Description
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 for new and existing Class II and Class III devices 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. **_Come for a job, stay for a career!_** **A Day in The Life Of:** Responsibilities may include the following and other duties may be assigned. * 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 documentati
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