Regulatory Affairs Specialist

3 weeks ago

Malta Konnekt Full time

Our client, a global healthcare organization is recruiting for Regulatory Affairs Specialists to join their team. Reporting to the Regulatory Affairs Manager, your duties would include;

Creating and reviewing regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals.
Interacting with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals.
Tracking status and progress of regulatory documentation that will be used for renewals.
Coordinating and compiling responses to regulatory authority renewal questions (under supervision)
Using an electronic document management system to compile documents to support product renewals for submission to Health Authorities
Answering internal queries for assigned products.
Maintaining Database of Regulatory Requirements for renewals

RequirementsRegulatory experience within a healthcare environment, specifically Medical DevicesAdministrative and project management skillsAbility to contribute to multiple projects from a regulatory affair perspectiveTechnical system skills (e.g. word processing, excel, SmartSheet, databases, online research)Ability to independently identify compliance risks and resolve or escalate as necessaryAbility to multitask and prioritizeBased LocallyEducation and ExperienceBachelor's degree or country equivalent in a relevant scientific discipline

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