Regulatory Affairs Jr. Specialist Consultant Mexico Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 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. Responsibilities Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Qualifications / Requisitos Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field. Minimum 1 year of experience in regulatory affairs, quality or medical device industry. Mexican medical device regulations (COFEPRIS). NOMs and standards applicable. Intermediate-advanced English (technical reading required). Organizational and documentation skills. Effective communication. Team collaboration Learning Agility. #J-18808-Ljbffr
Regulatory Affairs Jr. Specialist Consultant Mexico
CLINCHOICE INC.
estado de méxico, estado de méxico
Publicado hace 26 días
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