Regulatory Specialist
Job location

Agno, CH

Job type

Full-Time

Experience

3 years

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 Regulatory Specialist with minimum 3 years of experience in the regulatory field of medical devices or in vitro diagnostics, to strongly support our clients in efficiently transitioning to MDR.

Experience in pharmaceuticals, food supplements or cosmetics is also a plus.

Role with high career development opportunities.

Regulatory Specialist – Main Responsibilities
– Operational support to medical device/IVD development activities and product certification.- Support companies in MDR/IVDR transition with partnership in defining the winning strategy.- Gap analysis for understanding the need of clinical data necessary for MDR transition.

– Preparation of regulatory documentation: Technical documentation, Clinical Evaluation, Biological Evaluation, 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.

– Preparation of 510(k) files for medical devices to be marketed in the USA in accordance with FDA regulations.

Regulatory Specialist – Requirements

Education:

– Scientific degree, preferably Biology, Biotechnology, Pharmaceutical Chemistry or Biomedical Engineering.

Experience:

– At least 3 year(s) of experience in the regulatory field of medical devices, in vitro diagnostics.

– Experience with EU and Extra EU MD registration processes.

– Experience in FDA’s 510(k) and PMA processes is a plus.

Skills:

– Fluency in English is a must.

– Knowledge of applicable Regulations to the field of medical devices (ISO 13485, 21 CFR part 820, MDR 2017/745), in vitro diagnostics (IVDR 2017/746).

– 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!