Regulatory Affairs Lead
2 days ago
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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