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Technical Specialist & Scheme Manager - Active Devices
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Job Description
- Req#: JR0011791
- 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 2012 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 EC certifications.
- A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
- Bachelor's degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics
- Understand the principles of design control and risk management
- Have strong interpersonal communication skills
- Be capable of prioritizing and executing individual workload
Great that you're thinking about a career with BSI!
Great that you're thinking about a career with BSI!
BSI is seeking experienced R&D Engineers to join our Active Devices team as a home-based Technical Specialist & Scheme Manager.
As a Technical Specialist & Scheme Manager, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.
Technical Specialist Responsibilities:
Education/Qualifications:
What we offer:
The salary for this position can range from $113,500 to $140,000 annually plus 10% bonus; 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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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.About the company
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