Regulatory affairs specialist
Pyramid Consulting, Inc
Job Description
Job Title: Regulatory Affairs Junior SpecialistEmployment 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).
Int...
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).
Int...