Medtronic
Healthcare
RegulatoryAffairsSpecialist
“Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Medical devices, Global regulatory requirements. Lead submissions. Compile submission 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.
Compile submission materials
Compile license renewal materials
Compile annual registration materials
Address agency questions
Provide support to marketed products
Review product changes
Review process changes
Review supportive documentation
Prepare submissions for FDA
Prepare reports for FDA
Provide support for international submissions
Maintain worldwide regulatory requirements proficiency
Establish RA department relationships
Maintain RA department relationships
Establish cross functional team relationships
Maintain cross functional team relationships
Develop positive relationships with device reviewers
Maintain positive relationships with device reviewers
Assist in negotiations with FDA
Assist in negotiations with regulatory agencies
How You'll Work.
Team & Collaboration
Cross functional teams; RA department; Device reviewers
Communication Scope
Written communication; Verbal communication
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