Position Details

Salary $80K – $200K USD / year

Type Full-Time

Experience senior

Exp. Years 8+ years

Education Not specified

Category Consulting & Advisory

About this role

Senior Consultant focusing on regulatory information management (RIM) for MedTech customers, leading regulatory transformations and deployments of RIM applications, with emphasis on global regulatory needs and stakeholder engagement.

Key Responsibilities

Lead MedTech customer through regulatory transformation via RIM implementations
Analyze and translate requirements into solution designs
Define roll-out strategies across global regulatory teams
Manage communication between project team, customer, and internal stakeholders
Mentor project team and junior consultants

Technical Overview

Experience with RIM systems (Veeva Vault, OpenText, Trackwise, etc.), regulatory submissions and publishing, data management, cloud deployments in a consulting setting.

Ideal Candidate

The ideal candidate is a senior management/consulting professional with 8+ years implementing regulatory information management in life sciences, strong stakeholder management, and ability to travel up to 50% in a US-based role.

Must-Have Skills

8+ years experience implementing regulatory information management systemsExperience with global regulatory requirementsAbility to travel up to 50%Strong stakeholder management

Nice-to-Have Skills

Direct experience with systems such as Veeva VaultPARAXEL/LIQUENT InSightCSC Regulatory TrackerArisGlobal RegisterOpenTextIQVIATrackwiseConsulting experienceRegulatory AffairsRegulatory Operationsor Submissions Management backgroundLife Sciencecomputer sciencebiochemical and mechanical engineers or related degreeSaaS/Cloud experience

Tools & Platforms

Veeva VaultPARAXEL/LIQUENT InSightCSC Regulatory TrackerArisGlobal RegisterOpenTextIQVIATrackwise

Required Skills

Regulatory information managementSubmissionsGlobal regulatory requirementsStakeholder managementConsulting

Hard Skills

Regulatory information management (RIM)Regulatory data managementSubmissionsSubmissions ArchiveRegistrationsPublishingGlobal regulatory requirementsStakeholder managementConsulting experienceLife sciences compliance

Soft Skills

Stakeholder managementCritical thinkingCommunicationMentoringPresentation

Industry & Role

Industry Healthcare IT

Job Function Lead regulatory information management implementations for MedTech customers

Role Subtype Management Consultant

Tech Domains Regulatory information management, Submissions management, Data migration, Systems integration, Veeva Vault, OpenText, IQVIA, Trackwise

Keywords for Your Resume

Senior Consultant - MedTech RIMRegulatory information managementRIMSubmissionsSubmissions ArchiveRegistrationsPublishingRegulatory AffairsRegulatory OperationsVeeva VaultOpenTextIQVIATrackwisePARAXEL/LIQUENT InSightCSC Regulatory TrackerArisGlobal RegisterConsultingRegulatory complianceSaaSCloudRemoteTravel up to 50%

Deal Breakers

8+ years of RIM implementation experience, Ability to travel up to 50%, US-based candidates preferred

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