Medtronic
Healthcare Technology
RegulatoryAffairsSpecialist
“Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Regulatory submissions, Compliance. Prepare regulatory submissions. Publish regulatory submissions”
Industry & Context.
Troubleshooting
Minimum 4 days a week onsite
What They're Looking For.
Must Have
Baccalaureate degree, 2 years of relevant experience
Nice to Have
Experience with regulatory data systems, Experience preparing regulatory submissions, Attention to detail, Organizational skills, Ability to manage multiple projects, Ability to meet deadlines, Effective written communication skills, Effective verbal communication skills
What You'll Do.
Prepare regulatory submissions
Publish regulatory submissions
Perform quality control on submissions
Deliver regulatory submissions
Produce submissions using electronic publishing tools
Manage enterprise-wide regulatory management systems
Coordinate regulatory systems
Support regulatory system users
Maintain regulatory system data
Develop training for colleagues
Deliver training for colleagues
Contribute to regulatory systems development
Contribute to regulatory systems implementation
Contribute to regulatory systems improvement
Provide input to system design
Provide input to system enhancements
Prepare paper submissions
Prepare electronic submissions
Submit annual reports
Submit general correspondence
Submit adverse event reports
Submit promotional material filings
Archive paper submissions
Archive electronic submissions
Collaborate cross-functionally
Collect required information
Provide regulatory status updates
Report out to leadership
How You'll Work.
Team & Collaboration
Cross-functional teams; Diverse stakeholder groups; R&D; Quality; Clinical; Marketing
Communication Scope
Report-outs to leadership
Process & Methodology
Project delivery
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