Medical device technical expert - Contraceptives

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.