About The Position
BSI is a designated European Notified Body, an accredited ISO 13485 certification body, and a recognized Auditing Organization under MDSAP. This is a home-based position with up to 25% travel. The role involves delivering Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management, and ISO 13485 QMS assessment services. The Technical Specialist will provide advice and support on certifications in their area of expertise, participate in client meetings, and offer leadership and mentoring to medical devices personnel. Additionally, 'Technical Sales/Networking' support may be required.
Requirements
- 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
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
Benefits
- group-sponsored health and dental
- short-term and long-term disability
- company-matched 401k plan
- company paid life insurance
- 11 paid holidays
- 4 weeks paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
