Medical Device Specialist with Contraceptives Expertise

1 month ago


Singapore BSI Full time
Company Overview

BSI is a leading certification body and Notified Body, offering ISO 13485-certification services. We are committed to excellence in product testing and evaluation.

Estimated Salary: $120,000 - $160,000 per annumJob Description:

We are seeking a Medical Device Technical Specialist with expertise in contraceptives, including condoms and lubricant gel-related medical devices. Our Technical Specialists are industry experts who deliver high-quality services, providing advice on certifications and regulatory challenges.

Key Responsibilities:
  1. Deliver CE Marking technical reviews under MDD and MDR requirements, scheme management, and ISO 13485 QMS assessment services.
  2. Provide expert advice and support on certifications in areas of expertise that may have regulatory challenges.
  3. Participate in client meetings to facilitate CE marking processes.
  4. Lead and mentor medical device personnel in areas of competence.
  5. Support sales and networking efforts as needed.
Requirements:
  1. Bachelor's degree or higher in a discipline relevant to medical device design, manufacture, and use, or equivalent qualification.
  2. At least five years' post-graduate experience in the design and development of contraceptive medical devices/products, including design control, risk management, performance, and clinical evaluation.
  3. Knowledge of medical device regulations.
  4. Awareness of certification business processes, quality management standards, and audits.
Benefits:
  • Exposure to clinical, risk management, biological safety, and validation.
Our Culture:

At BSI, we value our people and strive for excellence in all aspects of our work. We believe in working collaboratively to achieve success and prioritize client-centricity, agility, and collaboration in everything we do.



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