Technical Specialist & Scheme Manager - General Devices

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.

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.