Technical Specialist & Scheme Manager- General Devices

We exist to create positive change for people and the planet. Join us and make a difference too!

BSI is a designated European Notified Body, an accredited ISO 13485 certification body, and a recognized Auditing Organization under MDSAP. Are you looking to join a dynamic global industry leader that can boast nearly 120 years of excellence, growth, and continuing innovation? Do you hold yourself to the highest of standards? If yes, then we would love to hear from you.

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety - this may be a great fit for you! This is a home-based position with up to 25% travel.

Essential Responsibilities:

• Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management and ISO 13485 QMS assessment services.
• Provide advice and support on certifications in area of expertise that may have a regulatory challenge.
• Participate in client meetings to facilitate CE marking processes.
• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.
• Provide "Technical Sales/Networking" support as needed

The ideal candidate will possess the following characteristics:

• Bachelor's degree or higher in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.
• At least five (5) years' post-graduate experience in the design and development of medical devices in area of experience, including the principles of design control, risk management and performance and/or clinical evaluation
• Knowledge of medical device regulations.
• Awareness of certification business processes, the application of quality management standards, and audits

The salary for this position can range from $120,000 to $154,000 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

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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.