Homeoffice Medical device technical expert - Contraceptives with verification

Great that you're thinking about a career with BSI!Excited to grow your career?Our people make all the difference in our success.BSI is a designated European Notified Body, an accredited ISO 13485-certification body, a recognized Auditing Organization under MDSAP, and we have an opportunity for you to join our growing team! We are seeking a Medical Device Technical Specialist with contraceptives expertise to include condoms and Lubricant gel related medical devices.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 (when COVID-19 travel restrictions lift).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 contraceptive medical devices/products, 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 .

Advantages

• Exposure to clinical, risk management, biological safety and validation.

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 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.