Regulatory affairs specialist

Job Title: Regulatory Affairs Junior Specialist

Employment Type: Full-Time

Location: Onsite in Mexico City, Mexico

Language: Intermediate English (B1-B2)

Job Description:

Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations.

Qualifications / Requirements:

Bachelor's degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.

Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.

Experience:

Minimum 1 year of experience in regulatory affairs, quality or medical device industry.

Technical skills

Mexican medical device regulations (COFEPRIS).

Medical device classification.

NO...