![Artixio Consulting Pvt Ltd](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Manager Devices
hace 3 días
**Regulatory Affairs Manager (Medical Devices) - Mexico Position**
**Overview**:
**Responsibilities**:
- **Medical Device Registration**:
- Lead the registration process for medical devices with **COFEPRIS**.
- Determine the appropriate classification of devices based on the risk-based system.
- Prepare and compile all necessary documentation, including technical specifications, clinical data, labeling, and quality management system evidence.
- **License Transfer**:
- Facilitate license transfer processes for medical devices.
- Coordinate with relevant authorities and stakeholders to ensure seamless transitions.
- Maintain compliance during license transfers.
- **Project Management**:
- Manage multiple projects simultaneously.
- Develop project plans, set milestones, and allocate resources effectively.
- Monitor progress, identify risks, and implement corrective actions.
- Collaborate with cross-functional teams to achieve project goals.
- **Leadership and Team Management**:
- Provide strategic guidance and mentorship to team members.
- Foster a collaborative and results-driven environment.
- Lead by example, demonstrating a commitment to excellence and adherence to timelines.
**Qualifications**:
- Bachelor’s degree in a relevant field (e.g., life sciences, engineering, regulatory affairs).
- **Minimum 5 years** of experience in medical device regulatory affairs in Mexico.
- In-depth knowledge of **COFEPRIS** regulations and registration processes.
- Experience with license transfers and familiarity with quality management systems (e.g., ISO 13485).
- Strong project management skills, including the ability to prioritize tasks and meet deadlines.
- Excellent communication and leadership abilities.
**Additional Information**:
- Location: Mexico City, On Site
If you are a proactive, detail-oriented professional with a passion for regulatory compliance and a track record of successful project management, we encourage you to apply Please submit your resume and a cover letter outlining your relevant experience and achievements.
**Job Types**: Full-time, Contract
Contract length: 12 months
**Salary**: $30,000.00 - $80,000.00 per month
**Experience**:
- Medical Device Regulatory Affairs: 5 years (required)
Application Deadline: 20/03/2024
Expected Start Date: 01/04/2024
-
Regulatory Affairs Specialist
hace 4 semanas
Tlahuac, México Bayer A tiempo completo**Regulatory Affairs Specialist** **Position purpose** Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to...
-
Regulatory Affairs Manager Jr
hace 1 mes
Tlahuac, México Zoetis A tiempo completo**Role Description** The Regulatory Affairs Manager Jr. (RAMJr.) will be responsible for executing the strategies previously defined by the RASrM, will also support the promotion of compliance, advising other Departments about local regulations (COFEPRIS, SADER and PROFECO) and global procedures. Together with the RASrM, will identify possible impacts of...
-
Regulatory Affairs Manager
hace 3 semanas
Tlahuac, México Essity A tiempo completo**Regulatory Affairs Manager ***: In Tork we want to shape the PH market, so we are looking for someone to provide market-relevant regulatory input for the Latam region and to build a strong base of global assortment adapted for national regulatory compliance. **About the Role**: Ensures that the assigned product assortments (from different Legal...
-
Manager Regulatory Affairs Affiliate
hace 3 semanas
Tlahuac, México Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Regulatory Affairs and Policy
hace 1 mes
Tlahuac, México HSBC A tiempo completo-Job description **Role purpose**: Regulatory Affairs deals with regulators and / or regulatory developments affecting the Bank, and in particular as they relate to Compliance risks, which include and are not limited to: - Regulatory Engagement: Delivering proactive and more consistent management and oversight of regulator relationships...
-
Regulatory Affairs Specialist
hace 3 semanas
Tlahuac, México Edwards Lifesciences A tiempo completoMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...
-
Regulatory Affairs Specialist
hace 4 semanas
Tlahuac, México Abbott Laboratories A tiempo completo**Regulatory Affairs Specialist** **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 learn, care for...
-
Regulatory Affairs Specialist, Export Countries
hace 3 semanas
Tlahuac, México Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) Mexico City 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...
-
Regulatory Affairs Jr Specialist
hace 3 semanas
Tlahuac, México Johnson & Johnson A tiempo completoDescription Kenvue is currently recruiting for: **Regulatory Affairs Jr Specialist** This position reports to Latam CMC Regulatory Affairs Manager and is based at Mexico City. **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands -...
-
Global Regulatory Affairs Lcm&e
hace 2 meses
Tlahuac, México Bayer A tiempo completo**Global Regulatory Affairs LCM&E** **Your Tasks and Responsibilities** - Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early...
-
Global Regulatory Affairs Lcm&e
hace 4 semanas
Tlahuac, México Bayer A tiempo completo**Global Regulatory Affairs LCM&E** **Your Tasks and Responsibilities** - Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early...
-
Regulatory Affairs Associate Consultant
hace 3 semanas
Tlahuac, México ClinChoice A tiempo completoAre 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** to join one of our clients. **Main Job Tasks and Responsibilities**: -...
-
Regulatory Affairs Manager
hace 3 semanas
Tlahuac, México Capital Empresarial Horizonte A tiempo completoCapital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. **Perfil**: Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés:...
-
Regulatory Affairs Associate Consultant-plm
hace 4 semanas
Tlahuac, México ClinChoice A tiempo completoAre 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** to join one of our clients. **Main Job Tasks and Responsibilities**: -...
-
Regulatory Affairs Analyst
hace 2 semanas
Tlahuac, México Johnson & Johnson A tiempo completoEn **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 ha estado impactando la salud de más de mil millones de pacientes y...
-
Regulatory Affairs Manager
hace 4 semanas
Tlahuac, México Capital Empresarial Horizonte A tiempo completoCapital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. **Perfil**: Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés:...
-
Strategic Affairs Sr. Manager
hace 2 semanas
Tlahuac, México Johnson & Johnson A tiempo completoAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for...
-
Regulatory Affairs Director
hace 6 días
Tlahuac, México GSK A tiempo completo**Site Name**: Mexico - Federal District - Mexico City **Posted Date**: Mar 6 2024 **_ Your Responsibilities_**: Are you looking for an opportunity for Strategic planning and execution for obtaining the approval of Vaccines, Pharmaceutical and ViiV pipeline, as well as for new projects? If so, this is the role for you. YOU will need the ability to Develop...
-
849a - Regulatory Affairs Specialist Ii (Anual)
hace 5 días
Tlahuac, México Merit Medical Systems Inc. A tiempo completoWork Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. ESSENTIAL FUNCTIONS...
-
Regulatory Engagement Lead
hace 2 semanas
Tlahuac, México Citi A tiempo completo**Responsibilities**: - Responsible for providing risk strategic analytics, information management across Citibank products and reports to senior management. - Responsible for communicating to executive management implications of existing and opposed regulation and developing potential responses. This may include regulations related to specific product or...