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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