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Labelling Lead - Drug Regulatory Affairs

2.00 to 10.00 Years   UAE   23 Oct, 2019
Job LocationUAE
EducationNot Mentioned
SalaryNot Mentioned
IndustryNot Mentioned
Functional AreaNot Mentioned

Job Description

Our client, a global pharmaceutical giant is now on the search for a labeling - Artwork specialist to be employed in their Drug & regulatory affairs department.The responsibilities include the following:Act as advisory to Medical Device clients and project teams delivering labeling servicesProvide technical Device Labeling Artwork, print production, Change Notices, globally.Proofs, edits, and manages labeling documents.Updates designated databases/ internal sites containing department information according to standard operating procedures (SOPs).Tracks correction and preventative actions (CAPAs) and department metricsProvides summary reports to department management and designated stakeholders. REQUIREMENTS: What we are looking for, is a candidate who demonstrate expertise in the following:Graphic, Print design, and Print systems (Adobe Suite (Illustrator, InDesign, Photoshop), Bartender, Label view, Code Soft, Prysm, etc.)Excellent oral and written communication skillsExcellent attention to detailKnowledge of Medical Device Quality System Regulations & QMS:(FDA 21CFR Part 820, ISO 13485, GDP)Medical Device Regulation [EU MDR 2017/745]Knowledge of EU Medical device regulation like o Medical Device Directive 93/42/EECExperience in the review and approve advertising and promotional materials (US, EU and Global) a plusExcellent written (Technical Writing) and Verbal communication skillsGood knowledge of Materials, Manufacturing process and capabilitiesAbility to identify Compliance Risks and Escalate when necessary.Change control ProcessThe ideal candidate will have nearly 3 years of experience with a Bachelors Degree in relevant field of Study

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About Company

Transguard Workforce Solutions delivers Professional Contract Staffing (also known as Employee Outsourcing) within the UAE.

Our Workforce Solutions include:

Delivering Sourcing and Recruitment Solutions for Clients in need of identifying Contract or temporary Staff.

Providing a complete end to end Staffing Solution which includes Visa Sponsorship, HR Management, Employee Welfare & Payroll Services.

Transitioning Contract Staff from other staffing providers to Transguard while remaining compliant with UAE Labour and Immigration Laws.

Transguard Workforce Solutions currently employ over 2000+ Staff from over 70 different nationalities. Across the Group, we payroll over 70,000 employees monthly.

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