Job Details
Job location

Agno, CH

Job type

Full-Time

Experience

1-2 years

Junior Regulatory Specialist

1MED SA, Contract Research Organization that provides clinical and regulatory services for medical devices, in vitro diagnostics and pharmaceuticals, is hiring!

We are looking for a Junior Regulatory Specialist with 1-2 year(s) of experience in the regulatory field of medical devices and and in-vitro diagnostics.

Role with high career development opportunities.

Junior Regulatory Specialist – Key responsibilities:

  • Operational support to medical device and in-vitro diagnostics development activities and product certification.
  • Preparation of regulatory documentation for the CE marking of medical devices and in-vitro diagnostics: Technical documentation, Clinical Evaluation and Post-market Clinical Follow-up
  • Support to client(s) for the preparation of post-market surveillance and risk management documentation, Instructions for Use and labelling.
  • Dialogue with Notified Bodies, national and international Competent Authorities for authorization procedures and certifications of medical devices and in-vitro diagnostics.
  • Preparation of 510(k) files for medical devices to be marketed in the USA in accordance with FDA regulations.

Junior Regulatory Specialist – Requirements:

Education:

  • Scientific degree, preferably Biology, Biotechnology, Pharmaceutical Chemistry

Experience:

  • 1-2 year(s) of experience in the regulatory field of medical devices and / or in-vitro diagnostics

Skills:

  • Fluency in English is a must
  • Knowledge of the Medical Device Regulation and IVDR
  • Good diplomatic and interpersonal skills
  • Precise, constant, proactive, collaborative attitude with marked problem solving attitude

To join us in this exciting new venture, please contact us!