1016 empleos en Tijuana, Baja California

Especialista de Cumplimiento Regulatorio (ISO 13485)

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 2 horas en Tijuana

Especialista de Cumplimiento Regulatorio (ISO 13485) - Foránea

Thermo Fisher Scientific (Planta Tijuana)

A positive approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at all levels Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A continuous improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). Ensure availability of up-to-date technical documentation and Standard Operating Procedures Work together with LPE global teams for supporting customer requests with related RA mailboxes Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods Support international registrations with related technical documentation Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

Hace 2 horas en Monterrey