Glutalor Medical Inc, based in Exton, PA , specializes development and manufacture of advanced continuous glucose monitoring products.  It offers advantage of factory calibration and no inserting device for sensor placement.   Its leading product iWel CG2 is currently being launched in European market.

Responsibilities

  • Lead in quality (QA/QC) and regulatory affairs for our product portfolio
  • Lead in setting up and certification of QMS and ISO-13485 for manufacturing medical products
  • Coordinate efforts in drafting and submitting regulatory packages for approval
  • Manage contract manufacturers and vendors to ensure product quality

Qualifications

  • Advanced training in life sciences, chemical engineering or related field
  • Minimum 10+ years of experiences in FDA regulated medical device industry and a minimal of 5 years in management positions
  • Extensive knowledge and experience in quality and regulatory submissions with EU and FDA
  • Extensive knowledge of ISO-13485 certification and compliance
  • Excellent communication and personal skills

Flexible schedule: part-time or full-time.  Employee benefit including healthcare coverage

To apply: send your resume to info@glutalormed.com