78 days ago on hays.ch

Senior Regulatory Affairs Officer (m/f)

Hays (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

Senior Regulatory Affairs Officer (m/f)

On behalf of our customer, a renowned bio-manufacturing company, we are looking for a

Senior Regulatory Affairs Officer (m/f)

for a permanent position in the Geneva region
  • Reference number:
    317185/11
Your Duties:
  • Provide advice and guidance on regulatory requirements throughout product development projects
  • Review analytical data (development studies, performance evaluation studies and clinical field trials) in order to ensure regulatory requirements are met
  • Response to requests from regulatory authorities
  • Preparation of technical and regulatory dossiers in order to provide support for product licenses applications
  • Documentation of changes in accordance with quality systems requirements
  • Support the implementation of the quality policy according to GMP; ISO 13485; 98/79/EC IVD directive, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP)
Your Qualifications:
  • Master degree (or equivalent) in Life Sciences
  • Profound knowledge in biology, biochemistry, immunology and/or virology
  • Relevant experience in regulatory in the life sciences industry as well as in interfacing with regulatory authorities
  • Experience in biologic licence application (BLA) and premarket approval (PMA)
  • Fluency in English