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Labelling Lead - Drug Regulatory Affairs

Transguard Workforce Solutions

Dubai, UAE

Ref: RP117-340

Job description / Role

Employment: Full Time

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 services
• Provide 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 metrics
• Provides summary reports to department management and designated stakeholders.


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 skills
• Excellent attention to detail
• Knowledge 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/EEC
• Experience in the review and approve advertising and promotional materials (US, EU and Global) a plus
• Excellent written (Technical Writing) and Verbal communication skills
• Good knowledge of Materials, Manufacturing process and capabilities
• Ability to identify Compliance Risks and Escalate when necessary.
• Change control Process
• The ideal candidate will have nearly 3 years of experience with a Bachelors Degree in relevant field of Study

About the 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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