Position Details

Type Not Specified

Experience mid

Exp. Years 0+ years

Education Master's degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology

Category Healthcare & Medical

About this role

This role involves managing the regulatory database to ensure compliance, audit readiness, and accurate product records within the medical device and diagnostics industry.

Key Responsibilities

Manage regulatory database
Ensure audit readiness
Handle registration requests
Verify data accuracy
Provide user training and support

Technical Overview

Technical scope includes regulatory database management, compliance monitoring, and supporting global registration processes, utilizing electronic submission platforms and document control systems.

Ideal Candidate

The ideal candidate is a regulatory affairs professional with a master's degree and experience managing regulatory databases within the medical device or diagnostics industry. They should be detail-oriented, knowledgeable about global regulations, and capable of supporting compliance activities.

Must-Have Skills

Master's degreeExperience in Regulatory AffairsProficiency in regulatory systems/toolsKnowledge of global regulatory frameworks

Nice-to-Have Skills

Familiarity with product lifecycle strategiesMarket access planning

Tools & Platforms

Electronic submission platformsDocument control systems

Required Skills

Regulatory database managementRegulatory complianceProduct registrationData validationAudit readinessRegulatory submissionsGlobal regulatory frameworksEU MDRIVDRFDAHealth CanadaPMDA

Hard Skills

Regulatory database managementRegulatory complianceProduct registrationData validationAudit readinessRegulatory submissionsGlobal regulatory frameworksEU MDRIVDRFDAHealth CanadaPMDA

Soft Skills

Attention to detailOrganizational skillsTraining and supportCommunicationRegulatory knowledge

Industry & Role

Industry Healthcare & Medical

Job Function Manage regulatory database to ensure compliance and registration accuracy

Keywords for Your Resume

Regulatory AffairsRegulatory databaseProduct registrationAudit readinessRegulatory complianceGlobal regulatory frameworksEU MDRIVDRFDAHealth CanadaPMDARegulatory systemsElectronic submission platformsDocument control systems

Deal Breakers

Lack of regulatory affairs experience, No experience with regulatory systems/tools, No master's degree in relevant field

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Regulatory Affairs Professional, Database

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