Regulatory Affairs Specialist

hace 2 semanas

Chihuahua, México Bepc Inc A tiempo completo

Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices- Communicate with regulatory authorities to obtain timely approvals for medical devices- Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations- Monitor regulatory changes and provide guidance to cross-functional teams on potential impact to business- Participate in cross-functional teams to ensure regulatory compliance throughout the product lifecycle- Assist with the preparation and conduct of regulatory inspections and audits- Maintain regulatory files and ensure documentation is up-to-date and accurateQualifications:- Bachelor's degree in a scientific discipline- 3+ years of experience in Regulatory Affairs in the Medical Device industry- Strong understanding of US and international regulations related to medical devices, including FDA, EU MDR, and other global regulations- Experience preparing and submitting regulatory filings for medical devices- Excellent communication, organizational, and analytical skills- Ability to work independently and in a team environment- Strong attention to detail and ability to manage multiple projects simultaneously.Tipo de puesto: Tiempo completoHorario:- Horas extra- Lunes a viernesPrestaciones:- Seguro de vidaPuede trasladarse/mudarse:- Ciudad Juárez, Chih.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)Experiência:- industria medica: 3 años (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencial

  • Regulatory affairs specialist

    hace 2 semanas

    Chihuahua City, México ClinChoice A tiempo completo

    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....Clin Choice is searching for a Regulatory Affairs Specialist – Consultant (Sr. Product License Maintenance Manager, (PLM) Compliance Support) for 12...

  • Customs Affairs Specialist

    hace 2 semanas

    Chihuahua, México findojobs A tiempo completo

    **EMPRESA CONFIDENCIAL****Solicita**:Customs Affairs Specialist****Descripción y Requisitos**Location?Juarez, Tijuana, GuadalajaraBe responsible for Mexican customs affairs daily operation, assisting group business units to make local import/export business running smoothly, providing data and report to manage group customs risk and protect group benefit.1....

  • CSV & Regulatory QA Specialist II

    hace 2 semanas

    Chihuahua, México Jabil A tiempo completo

    A leading manufacturing firm located in Chihuahua, Mexico is seeking a Software Quality Assurance Specialist II. In this role, you will ensure compliance of computerized systems with regulatory requirements, such as FDA and ISO standards. Responsibilities include leading validation efforts, supporting regulatory audits, and training cross-functional teams....

  • CSV & Regulatory QA Specialist II

    hace 2 semanas

    Chihuahua, México Jabil A tiempo completo

    A leading manufacturing firm located in Chihuahua, Mexico is seeking a Software Quality Assurance Specialist II. In this role, you will ensure compliance of computerized systems with regulatory requirements, such as FDA and ISO standards. Responsibilities include leading validation efforts, supporting regulatory audits, and training cross-functional teams....

  • Regulatory Affairs Engineer

    hace 2 días

    Chihuahua, México Jabil Circuit A tiempo completo

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...

  • Regulatory Affairs Engineer

    hace 11 horas

    Chihuahua, México Jabil Circuit A tiempo completo

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...

  • Senior Specialist Eq Supplier Quality

    hace 2 semanas

    Chihuahua, México Johnson & Johnson A tiempo completo

    Janssen Supply Group, LLC is recruiting for a Senior Specialist, EQ Supplier Quality!Remote work options may be considered on a case-by-case basis and if approved by the Company.We are part of the Janssen Supply Chain (JSC), a global organization responsible for supplying medicines to markets and patients around the world.With Supplier Quality as our primary...

  • Senior Regulatory Compliance Specialist

    hace 2 semanas

    Chihuahua, México Johnson & Johnson A tiempo completo

    **Job Function**:Legal & Compliance**Job Sub Function**:Enterprise Compliance**Job Category**:Professional**All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico**About MedTech**Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.**About...

  • Staff Regulatory Compliance Specialist

    hace 2 semanas

    Chihuahua, México Johnson & Johnson A tiempo completo

    **Job Function**:Legal & Compliance**Job Sub**Function**:Enterprise Compliance**Job Category**:Professional**All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico**About MedTech**Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.**About...

  • Customs Analyst Ii

    hace 2 semanas

    Chihuahua, México Johnson & Johnson A tiempo completo

    **Function**- Regulatory Affairs Group**Sub function**- Regulatory Affairs**Category**- Analyst, Regulatory Affairs (P4 - E24)**Location**- Ciudad Juarez / Mexico**Date posted**- Jun *********Requisition number**- R-********Work pattern**- Fully OnsiteDescription**Job Function**:Regulatory Affairs Group** Job Sub Function**:Regulatory Affairs** Job...