Technical Specialist & Scheme Manager - General Devices
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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.
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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.
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