Senior Regulatory Affairs Specialist
2 weeks ago
Job Title: Senior Regulatory Affairs Specialist
Job Summary:
We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team at Newton Colmore Consulting Ltd. As a Senior Regulatory Affairs Specialist, you will be responsible for managing regulatory affairs standards and quality management systems on our brand new IVD technology.
Key Responsibilities:
- Assist with the management of regulatory affairs standards and quality management systems
- Work closely with the quality assurance and design teams to ensure the success of the product
- Undertake internal audits to ensure compliance with regulatory standards
- Develop and implement regulatory strategies to ensure compliance with UK and European regulations
Requirements:
- Strong knowledge of regulatory standards within the UK and Europe
- Experience in the IVD market and FDA submissions
- Ability to work in a ISO 13485 environment
- Excellent communication and project management skills
About Us:
Newton Colmore Consulting Ltd is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors.
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