RA Specialist – West Yorkshire – Medical Device
About the Company:
We are looking for a regulatory affairs professional with experience in medical devices to join an organisation in the West Yorkshire area. This is a hybrid working role, however, 3 days per week will be site based.
Responsibilities:
• Technical file management and maintenance.
• Ensuring compliance with regulatory requirements.
• Ensuring legislative compliance for testing and labelling.
• Providing support to internal and external customers as well as suppliers.
• Post market surveillance.
• Complaint assessment.
• Regulatory support for new product introductions.
• Product recalls.
Requirements:
• Previous experience working within a regulatory affairs position with medical devices.
• Knowledge of MDD/MDR and ISO 13485.
• Experience with technical files.
• Excellent attention to detail.
• Excellent communication skills.
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