Medtronic
AssociateRegulatoryOperationsSpecialist
“Associate Regulatory Operations Specialist at Medtronic. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Regulatory Affairs Data and Product Release, Unique Device Identification (UDI) process and system, global regulatory compliance, data integrity, Regulatory Affairs teams, Operating Units, Regulatory Operations, enterprise-wide regulatory management systems, systems coordination, training”
What You'll Achieve.
ensure global regulatory compliance and data integrity; meet timelines; resolve regulatory issues; improve work processes
Industry & Context.
Analytical and problem-solving skills
What They're Looking For.
Must Have
Bachelor's degree required, 6 months to 1 year of experience, Advanced proficiency in English, High learning agility, Organizational skills and highly detail oriented, Flexible with changing priorities, self-motivated, work ethic, works well under pressure in a dynamic environment, Intermediate knowledge of spreadsheet and database applications (Microsoft Office, SharePoint, and Sitebuilder), Analytical and problem-solving skills, Document interpretation, queries and workflow skills, Excellent communication skills
Nice to Have
Experience in medical device, Experience with regulatory affairs or quality, Experience with UDI, Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation), Advanced communications skills (written and oral), Effective project management skills
What You'll Do.
supporting regulatory systems and processes
supporting our Unique Device Identification (UDI) process and system to ensure global regulatory compliance and data integrity
participating in projects supporting our Regulatory Affairs teams within the Operating Units and Regulatory Operations
Activities related to enterprise-wide regulatory management systems
including systems coordination
developing and implementing plans
and providing input to systems designs
Performs Regulatory Operations activities including data transformation to support global UDI submissions
Collaborates with global regulatory affairs teams and operation units to gather and analyze required information
Participates actively in cross-functional teams to meet timelines
resolve regulatory issues
and improve work processes
How You'll Work.
Team & Collaboration
interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager and director; being part of a global team; collaborating with business partners throughout the company; visibility to global structures and impacts; insight to various processes and functions across Medtronic; Collaborates with global regulatory affairs teams and operation units to gather and analyze required information; Participates actively in cross-functional teams to meet timelines, resolve regulatory issues, and improve work processes
Communication Scope
Excellent communication skills; Advanced communications skills (written and oral)
Process & Methodology
Effective project management skills
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