Assessment Specialist

2 days ago

Mumbai, Maharashtra, India beBeeProduct Full time

Job Overview:

As a Product Assessor, you will conduct thorough technical file reviews to ensure that products meet safety and performance standards in compliance with applicable regulations.

You will also support CE marking activities and communicate with colleagues and clients regarding product assessment and other tasks, focusing on minimizing risks associated with medical device certification.

Key Responsibilities:

  • Degree or equivalent experience in medicine, dentistry, biotechnology, engineering, or other relevant fields
  • 4+ years of professional experience in the orthopaedic/dental products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, a minimum of two years should be directly involved in the design, manufacturing, and testing of dental products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies.
  • Prior experience conducting orthopaedic or dental product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous
  • Strong communication and stakeholder management skills
  • Professional English language proficiency
  • Orthopaedic and Dental Device knowledge through designing, manufacturing, or testing of devices in some or all the following areas

Device Expertise:

  • Non-active osteo- and orthopaedic implants (MDN1102)
  • Prosthetic joint replacements (i.e., knee, hip, shoulder, elbow, wrist, ankle, fingers, etc. implants)
  • Artificial spinal disc, spinal cages
  • Bone graft substitute for orthopaedic indications, bone cements, etc.
  • Osteosynthesis devices such as orthopaedic nails, screws, plates, etc.

Additional Skills:

  • Medical implant technology expertise
  • Advanced knowledge of device regulatory requirements
  • Expertise in device documentation and record-keeping

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