Medical device technical expert - Contraceptives

Medical Device Technical Expert - Contraceptives

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Locations: United Kingdom - Homebased, Singapore - Homebased, Malaysia, China, France

Posted: 30+ Days Ago

Job Requisition ID: JR0007391

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.

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.