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Medical Device Regulatory Expert

2 months ago

Singapur, Singapore BSI Full time

Job Summary:

We are seeking a highly skilled Medical Device Technical Expert to join our team at BSI. As a Medical Device Technical Specialist, you will be responsible for delivering technical reviews, providing advice and support on certifications, and participating in client meetings to facilitate CE marking processes.

Key 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.

Requirements:

  • 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.

What We Offer:

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

Our Excellence Behaviours:

  • Client-centric
  • Agile
  • Collaborative