Regulatory Affairs Specialist

hace 7 meses


Ciudad Juarez, México BEPC Inc A tiempo completo

Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect Merit’s business and products, assisting with FDA facility inspections, Notified Body audits, and other internal audits. Performs duties with limited input from management and/or senior members of the department. Essential Functions Performed - Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required. - Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales. - Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation. - Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities. - Prepares IDEs and PMAs and assists with clinical trials when required. - Interacts with various levels of management, external agencies and companies. - Analyzes and makes recommendations regarding field complaints. - Develops, maintains and analyzes department systems and provides training when needed. - Remains current on developing regulations and revises systems as necessary. Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed. - Assists with supervision of department staff, as directed. - Performs other related duties and tasks, as required. Summary Of Minimum Qualifications - Education and/or experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience. - Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc. - Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers. - Self-motivated, self-directing, strong attention to detail and excellent time management skills. - Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others. - Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

COMPETENCIES - Regulatory submission/rationale preparation - Global Regulatory paths/strategies - Computer skills/internet research - Interpersonal/communication skills - Regulatory system development/training - Field Action coordination and reporting - Product development and change qualification processes

Tipo de puesto: Tiempo completo

Horario:

- Lunes a viernes

Prestaciones:

- Seguro de vida

Pregunta(s) de postulación:

- Whats your salary expectations?

Lugar de trabajo: Empleo presencial



  • Ciudad Juarez, 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...


  • Ciudad de México, CDMX Icon plc A tiempo completo

    Senior Regulatory Affairs Specialist - Mexico City - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development JR123070 Senior Regulatory...


  • Ciudad de México Solventum A tiempo completo

    **Regulatory Affairs Specialist, Mexico (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...


  • Ciudad de México, CDMX Solventum A tiempo completo

    Job Description: Regulatory Affairs Specialist, Mexico (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health,...


  • Ciudad de México Qiagen A tiempo completo

    **Overview** At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the...


  • Ciudad Juárez, México Fenixfarma Mexico City, Mexico A tiempo completo

    Regulatory Affairs Specialist Job description: Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico Immediate job! Chemist/ Biologist and also Pharmacist Diploma. Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Viewing, checking, preparing for submission to COFEPRIS, Printing, submitting. At least 1...


  • Ciudad de México, CDMX Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Lead and prepare RA meetings (regulatory status) involving the OU's under their responsibility....

  • Regulatory Affairs Expert

    hace 2 semanas


    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to lead our North American team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local, regional, and ICH regulations. Your expertise will play a critical role in supporting product development from preclinical stages...


  • Ciudad de México, CDMX Fenixfarma Mexico City, Mexico A tiempo completo

    Regulatory Affairs Specialist Job description: Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico Immediate job! Chemist/ Biologist and also Pharmacist Diploma. Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Viewing, checking, preparing for submission to COFEPRIS, Printing, submitting. At...


  • Ciudad de México, CDMX Fenixfarma Mexico City, Mexico A tiempo completo

    Regulatory Affairs Specialist Job description: Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico Immediate job! Chemist/ Biologist and also Pharmacist Diploma in order to act as sanitary responsible Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Printing, submitting. Including preparations of...


  • Ciudad de México, CDMX Abbott Laboratories A tiempo completo

    **Regulatory Affairs Specialist / Medical Devices** **Mexico City** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and...


  • Ciudad de México Johnson & Johnson SA de CV A tiempo completo

    **Regulatory Affairs Specialist** **-** **2306138354W** **Descripción** En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad. La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que...


  • Ciudad de México, CDMX 3M A tiempo completo

    Job Description: Collaborate with innovative 3Mers around the world As Regulatory Affairs Specialist you will play a key role for coordinating regulatory strategy for Mexico in the division of Consumer Health Group. In this role you will be able to provide support and expertise as part of the Regulatory organization using knowledge of Mexican regulatory...


  • Ciudad de México, Ciudad de México ICON A tiempo completo

    At ICON, we are seeking a Senior Regulatory Affairs Specialist to join our team in Mexico City.The ideal candidate will have a strong background in clinical trials and regulatory affairs, with experience in preparing and submitting regulatory documents.We offer a competitive salary of $95,000 per year, plus benefits such as annual leave entitlements, health...


  • Ciudad de México, Ciudad de México ICON Plc A tiempo completo

    Senior Regulatory Affairs SpecialistWe're seeking a highly skilled Clinical Trials Regulatory Affairs Expert to join our team at ICON Plc. This is an exciting opportunity to leverage your expertise in regulatory affairs and contribute to the success of our clinical trials.About the Role:Lead the preparation, submission, and maintenance of regulatory...


  • Ciudad Juarez, México Emprego MX A tiempo completo

    **EMPRESA CONFIDENCIAL** **Solicita**:Customs Affairs Specialist** **Descripción y Requisitos** Location?Juarez, Tijuana, Guadalajara Be 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...


  • Ciudad de México, Ciudad de México Novartis Farmacéutica A tiempo completo

    About the Role\As a Regulatory Affairs Leader at Novartis Farmacéutica, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the technical documentation change system.\The ideal candidate will have experience managing global regulatory submission projects, providing strategic input on regulatory strategy,...


  • Ciudad de México, CDMX AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...


  • Ciudad de México, CDMX MSD A tiempo completo

    El **ESPECIALISTA SR. DE ASUNTOS REGULATORIOS** ayudará en las actividades regulatorias de productos para dar soporte a nuestra empresa **Competencias**: - Garantiza el mantenimiento de los productos asignados y autorizados mediante la presentación oportuna de prórrogas y modificaciones a las condiciones de registro sanitario. - Para productos y...


  • Ciudad de México Bayer A tiempo completo

    **Regulatory Affairs Analyst** **Your task and responsabilities** - Support to the Regulatory Affairs area in the preparation and submission of dossiers for new registrations, variations, FSC and others. - Support to Clinical Operations on the submission of clinical research protocols and amendments. - Responsible for the submission of the advertising...