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Senior Medical Devices Regulatory Compliance Expert
2 weeks ago
We are seeking a highly skilled Medical Device Assurance Specialist to play a crucial role in ensuring the design and development of medical devices comply with regulatory requirements.
Main Responsibilities:
- Support and provide guidance for device development programs through the design and development lifecycle.
- Ensure compliance to design control requirements outlined in Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).
- Establish, maintain and provide guidance on the contents of Design History Files for development programs.
Requirements:
- Degree/Masters in engineering or science/life science.
- Proven experience in similar level/general experience in industry.
- Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.
- Strong problem solving and analytical skills.
- Excellent communicator; clear and concise in communications with External and Internal partners.
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