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.
