Regulatory Compliance Professional
6 days ago
Job Summary
We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.
Key Responsibilities
- Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals to ensure quality and compliance.
- Develop and maintain technical files and testing documentation to meet ISO 13485 standards.
- Conduct design assurance activities to ensure compliance with regulatory requirements.
- Work closely with our clients to understand their quality and compliance needs.
- Provide expert advice on quality and regulatory matters.
Requirements
- Relevant degree in a field related to Medical Devices or Quality Assurance.
- Proven experience in Quality Assurance and Regulatory Compliance.
- Strong knowledge of ISO 13485 and EN 60601 standards.
- Excellent communication and interpersonal skills.
What We Offer
- Competitive salary and bonus structure.
- Generous pension and life assurance scheme.
- Healthcare and other excellent benefits.
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