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:
- Scientific degree, preferably Biology, Biotechnology, Pharmaceutical Chemistry
- 1-2 year(s) of experience in the regulatory field of medical devices and / or in-vitro diagnostics
- 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!