Regulatory Affairs Specialist

Konnekt

Malta Island
€28,000-35,000 per year
Permanent
Full-time

1 month ago

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

Skill-sets and Requirements

Regulatory experience within a healthcare environment, specifically Medical Devices
Administrative and project management skills
Ability to contribute to multiple projects from a regulatory affair perspective
Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research)
Ability to independently identify compliance risks and resolve or escalate as necessary
Ability to multitask and prioritize
Based Locally

Education & Experience Bachelor's degree or country equivalent in a relevant scientific disciplineJob Reference: WG630Primary job focusScience & ResearchJob typeFull TimeEmployment levelExperienced (3 years +)Work LocationHybridEmployer industryHealthcareLanguagesEnglishScience & Research Jobs in Malta are require the collection, interpretation and analysis of data. Jobs in science and research roles include academic, business analysis, business intelligence, lab, market research, medical, pharma, R&D and statistics roles.

Konnekt

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