Medical Device Technical Expertise Lead
13 hours ago
At BSI, we're excited to grow our team with a Medical Device Technical Expertise Lead.
This is a home-based position with up to 25% travel (when COVID-19 travel restrictions lift).
Job OverviewWe are seeking a highly skilled professional to join our growing team as a Medical Device Technical Expertise Lead. This role will play a key part in delivering medical device CE marking technical reviews under MDD and MDR requirements, scheme management, and ISO 13485 QMS assessment services.
Responsibilities:- Delivery of Medical Device CE Marking Technical Reviews
- Advice and Support on Certifications
- Client Meetings for CE Marking Processes
- Leadership and Mentoring in Medical Devices
- Technical Sales/Networking Support
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 Years post-graduate experience in the design and development of contraceptive medical devices/products, including principles of design control, risk management, and performance and/or clinical evaluation.
- Knowledge of Medical Device Regulations.
- Awareness of Certification Business Processes, application of quality management standards, and audits.
Exposure to clinical, risk management, biological safety, and validation.
We offer an excellent compensation package for this role, with an estimated salary range of $95,000 - $120,000 per annum, depending on location and qualifications. This is a competitive salary, reflecting the importance of this role in supporting our clients' success.
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