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. NOMs and standards applicable. Intermediate-advanced English (technical reading required). Intermediate Excel skil...