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Medical Device Regulatory Expert
3 weeks ago
We are looking for an experienced Medical Device Regulatory Expert to join our team at TN Ireland. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and standards.
Main Responsibilities:- Regulatory Research: Conduct research on regulatory requirements and standards applicable to our products and services.
- Compliance and Risk Management: Identify products compliant or not with regulatory requirements, research alternative EU-based suppliers, and evaluate changes to the manufacturing and supply chain processes.
- Audit Preparation: Create and maintain audit-friendly product files for customers and HPRA assurance, lead management review process, and report on the performance of the quality system.
- Certification and Registration: Manage CE mark submissions, significant changes, and notified body interactions, and work with the commercial team to ensure country-specific registration activities are understood.
Requirements:
- A minimum of 5 years' experience in a medical device/healthcare industry in a regulatory position is necessary.
- Experience in conducting research on regulatory requirements and standards is essential.
- Strong analytical and problem-solving skills, attention to detail, and technical writing ability are required.
- You should have a good understanding of ISO 27001, MDD v MDR & CE/UKCA and be able to work in a fast-paced environment.
