Medical Device Compliance Specialist

2 days ago


Wakefield, Wakefield, United Kingdom TÜV SÜD Full time

Job Overview

The Medical Device Compliance Specialist will be responsible for ensuring that medical devices meet regulatory requirements. This role involves auditing clients' facilities to ensure compliance with relevant regulations and standards.

Key Responsibilities

  • Audit clients' facilities to ensure compliance with Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g., ISO 13485, ISO 14971)
  • Perform all related tasks, such as scheduling, planning, reviewing corrective actions, and preparing reports and audit documentation for submission to the certification committee of the Notified Body
  • Evaluate regulatory submissions, including product-specific Technical Documentation assessments and Design Dossier reviews
  • Provide project management for NAFTA-based customers, facilitate quote issuance, and coordinate with other TÜV SÜD America personnel
  • Identify and coordinate audit teams and communicate effectively with internal and external customers

Requirements

  • Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field
  • 3 years of experience in an industrial medical device environment in Product Design, Product Development, or Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products
  • At least 1 year of experience with quality management-related activities, such as design control, process/product/method validation, design transfer, risk management, manufacturing controls, or QC testing

Estimated Salary: $120,000 - $150,000 per annum, based on location and experience.

This role requires extensive domestic travel to client sites and some international travel may be required.



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