Medical Device Regulatory Specialist
hace 4 días
Company Overview:
Sgs is the world's leading testing, inspection and certification company. We operate a network of offices and laboratories, working together to enable a better, safer and more interconnected world.
Job Description:
We are seeking an experienced Medical Device Regulatory Specialist to join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new European In Vitro Diagnostics Regulation.
About the Role:
You will use your expertise in clinical diagnostic technologies to ensure that patients across Europe have access to safe and effective diagnostic tests. Your key task will be carrying out reviews of manufacturers' technical documentation as part of the CE marking process. This requires a keen interest in and deep understanding of product technologies being assessed, knowledge of clinical application of devices, and a keen eye for detail.
Main Responsibilities:
* Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices within a defined timeframe
* Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR
* Provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials
* Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification
Required Skills and Qualifications:
We are seeking a candidate with at least 4 years of professional experience within the domain of healthcare products or related activities. This may include roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical setting.
Salary: £60,000 - £80,000 per annum, depending on experience
Benefits:
Competitive salary and benefits package, opportunities for career development and growth, and a dynamic and supportive work environment.
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