Regulatory Affairs Lead

2 days ago


Wakefield, Wakefield, United Kingdom TÜV SÜD Full time

Regulatory Affairs Lead Job Summary

We are seeking a highly experienced Regulatory Affairs Lead to join our team. The successful candidate will be responsible for ensuring that medical devices meet regulatory requirements and providing project management for NAFTA-based customers.

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

Salary: $130,000 - $170,000 per annum, based on location and experience.



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