Job Title: Senior Medical Device Assurance Specialist
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About the Role:
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We are seeking a highly experienced Senior Medical Device Assurance Specialist to join our team in Dublin. In this key role, you will be responsible for ensuring the delivery of high-quality medical devices that meet regulatory requirements and customer expectations.
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As a Senior Medical Device Assurance Specialist, you will provide guidance and support to device development programs throughout the design and development lifecycle. This includes ensuring compliance with design control requirements, establishing and maintaining Design History Files, and collaborating with affiliated sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained.
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You will also support the integration and assessment of acquired combination products and medical devices into our Global Device Development product portfolio. Additionally, you will work closely with cross-functional teams to implement risk management activities for development programs through the implementation of ISO 14971:2019.
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Key Responsibilities:
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* Provide technical expertise in medical device assurance, including design control requirements, risk management, and quality management system.
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* Collaborate with device development teams to ensure compliance with regulatory requirements and customer expectations.
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* Establish and maintain Design History Files for development programs.
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* Support the integration and assessment of acquired combination products and medical devices into our Global Device Development product portfolio.
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* Work closely with cross-functional teams to implement risk management activities for development programs.
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Requirements:
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To be successful in this role, you will have a degree or master's in engineering or science/life science and at least 5-7 years of experience in a similar role or 5-10 years of general experience in industry. You will also need direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.
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Additionally, you will have experience in the implementation of device design controls and ISO/FDA requirements as applicable to device design. A demonstrated understanding of GMP, 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) is essential.
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Benefits:
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This is an excellent opportunity to join a leading organization in the pharmaceutical industry and contribute to the development of innovative medical devices. We offer a competitive salary and benefits package, including opportunities for career growth and professional development.
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What We Offer:
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In addition to a competitive salary and benefits package, we offer:
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* Opportunities for career growth and professional development.
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* A dynamic and supportive work environment.
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* The chance to work on exciting and challenging projects.
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* Access to cutting-edge technology and resources.
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