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Regulatory Affairs Specialist

1 month ago


West Yorkshire, United Kingdom Kinetica Full time

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.