Senior Regulatory Affairs Consultant - Remote (EU MDR)

Clinchoice; A distancia; MXN 1,093,000 - 1,458,000; Jornada completa

Descripción de la vacante

A global full-service CRO is seeking a Senior Regulatory Affairs Associate Consultant for a 12-month contract. This role involves collaborating with regulatory project teams, ensuring compliance with EU MDR, and maintaining communication regarding project status. The ideal candidate should have a Bachelor's degree in life sciences, at least a year of experience in regulatory affairs, and strong English communication skills. A commitment to quality and a supportive environment are part of the company's culture.

Formación

• 1+ years of experience in Medical Device Regulatory Affairs or training in Regulatory Affairs focused on EU MDR.
• Basic knowledge of ISO and EU MDD/MDR.

Responsabilidades

• Collaborate with the client's regulatory project team to collect necessary documents.
• Maintain knowledge of EU MDR and other global regulatory requirements.
• Perform quality-control checks per client's procedures.

Conocimientos

Knowledge of FDA MedTech regulations

Proficient in Microsoft Office

Strong written and verbal English communication

Educación

Bachelor's degree in life sciences

Descripción del empleo

A global full-service CRO is seeking a Senior Regulatory Affairs Associate Consultant for a 12-month contract. This role involves collaborating with regulatory project teams, ensuring compliance with EU MDR, and maintaining communication regarding project status. The ideal candidate should have a Bachelor's degree in life sciences, at least a year of experience in regulatory affairs, and strong English communication skills. A commitment to quality and a supportive environment are part of the company's culture.