Medical Device Technical Expert

2 weeks ago


Singapur, Singapore BSI Full time
Medical Device Technical Specialist

We are seeking a highly skilled Medical Device Technical Specialist with expertise in contraceptives, including condoms and lubricant gel related medical devices.

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 areas 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 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.

At BSI, we value client-centricity, agility, and collaboration. These behaviours represent how we do things at BSI, ensuring it's a great place to work and a highly successful business.

BSI conducts face-to-face interviews where possible. If you're invited to a face-to-face interview but prefer a virtual interview, please speak to a member of our recruitment team.



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