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Product Development Manager

Mission & Job description

  • Coordinate, control, and follow resources to manufacture company’s products according to schedules and quality policy
  • Drive implementation of quality standards in terms of production and regulatory documentation follow up
  • Be involved in R&D and V&V activities

Key responsabilities

  • Perform and/or assist with gap assessments between regulatory requirements and QMS.
  • Participate in Product and Process Qualification activities and establish the system, procedures, specification to ensure product quality meet the specified requirements.
  • Compilation of technical dossiers, regulatory submissions for target markets
  • Support Quality Manager in driving QMS process implementation and improvement.
  • Work with Software or Technical Team to ensure sufficient documentation and standardization
  • Participate in all aspects of medical device development activities such as:
    • Development plans
    • V&V tests
    • Compliance to standards
    • Production coordination
  • Participate in QA audits

Required skills, education & experience

  • Master’s degree biomedical engineering or equivalent.
  • 5 years’ experience in medical device.
  • Experience in CE and FDA (510(k)) certification process for electrical/electronic products
  • Proficient in IEC 60601/ IEC 62366
  • Knowledge in Quality System Regulation 21 CFR PART 820, ISO 13485
  • Knowledge of Class II and III medical device technical file submission will be a bonus
  • Soft skills: communication and technical writing
  • Fluency in French and English at minimum

Are you ready to join our team?

Please send your CV to Edouard: edouard.carton@gabismartcare.com