Technical Specialist & Scheme Manager - General Devices
We exist to create positive change for people and the planet. Join us and make a difference too! Technical Specialist & Scheme Manager – General Devices China – homebased About the role Our Regulatory Services team are looking for a Technical Specialist & Scheme Manager who will provide specialist regulatory, operational and strategic support as a scheme manager, products specialist to the business in the delivery of CE medical device marking schemes.
Responsibilities
Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2002 schemes. Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications. Closely work with Technical Team Managers to deliver operational efficiencies and maintain regulatory compliance requirements as a notified body. Establish regular communication with scheme clients and provide seamless certificate maintenance activities. To be a successful Technical Specialist & Scheme Manager, you will need: BSc, MSC or PhD degree in a discipline relevant to medical device manufacture and use, or equivalent qualification Thorough knowledge of the design and development of medical devices in area of experience, including the principles of design control, risk management and clinical evaluation Thorough knowledge of Medical Device regulation Concepts and intent of Product Certification and service orientation Knowledge of business processes and the application of quality management standards Conceptual and analytical thinking, efficiency and results orientation A team player good at relationship building internally and externally Broad technical understanding of client industry products Strong interpersonal communication skills. Ability of prioritizing and executing individual workload. BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 15-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, maternity leave, nursing leave, paternity leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle. #LI-Remote #LI-LH1
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.