Regulatory Affairs
hace 1 mes
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
At Boston Scientific, we want you to bring your unique strengths to our team. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. We believe that your diversity is our strength, and we are committed to fostering an environment where you can not only thrive but also bring your authentic self to work. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of who you are or where you come from.
Purpose Statement
The role is critical in linking with the executive management team for the country and in the relationships with the competent authorities/health authorities. Develops and manages a strong relationship with the competent authorities (covering product notifications, field actions, and any other specific program). Provides regulatory support and expertise to the local organizations. Manages the impact of the regional and national regulations on the business. Supports lobbying activities.
What we are looking for in you
Bachelor's degree in life sciences, engineering or related field required; advanced degree preferred. Minimum of 8 years of experience in regulatory affairs in the biotech, or pharmaceutical industry. Expert knowledge of COFEPRIS regulations, guidelines, and requirements. Knowledge of other international regulatory requirements is a plus. Strong communication, organizational, and project management skills. Ability to work in a fast-paced environment with changing priorities and tight timelines. Experience in medical device regulations is preferred. Ability to lead and work collaboratively with cross-functional teams.Key Responsibilities
Develop and implement regulatory strategies to ensure compliance with domestic and regional regulatory requirements. Advise cross-functional teams on regulatory requirements and assist with the interpretation and implementation of regulations. Manage the RA team to prepare and submit regulatory documentation aligned with the commercial strategy. Prepare regulatory assessments for changes in existing products. Develop and maintain registration and compliance records. Maintain awareness of changes in regulatory requirements and industry trends that could impact the organization. Build strong relationships and advocacy with regulatory authorities and participate in meetings and negotiations.Requisition ID: 579023
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
Tenemos otros empleos actuales relacionados con este campo que puede encontrar a continuación
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad Juarez, México BEPC Inc A tiempo completo**Regulatory Affairs Specialist** - 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 -...
-
Ciudad Juarez, México BEPC Inc A tiempo completo**BEPC is looking for**: **Regulatory Affairs Specialist** **Requirements**: - 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...
-
Regulatory Affairs
hace 1 mes
Benito Juarez, México Boston Scientific A tiempo completoAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad Juarez, México BEPC Inc A tiempo completoResponsible 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...
-
Regulatory Affairs
hace 1 mes
Benito Juárez, DF, México Boston Scientific A tiempo completoAdditional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Regulatory Affairs Manager
hace 3 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Regulatory Affairs Manager
hace 3 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Complaint Management Business Unit Manager
hace 3 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt **Johnson & Johnson Medical Devices Companies **, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and...
-
Principal Supplier Quality Engineer
hace 4 semanas
Ciudad Juarez, México Cardinal Health A tiempo completo**What does Supplier Quality bring to Cardinal Health** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying...
-
Sr. Marketing Specialist
hace 1 mes
Benito Juarez, México Boston Scientific A tiempo completoAdditional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Sr. Marketing Specialist
hace 1 mes
Benito Juarez, México Boston Scientific A tiempo completoAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
-
Senior Scientist
hace 4 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completo**Senior Sterility Assurance Scientist** At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...
-
Senior Quality Engineer 2nd Shift
hace 3 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Senior Quality Engineer
hace 3 semanas
Ciudad Juarez, 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...
-
Quality Engineer Ii
hace 3 semanas
Ciudad Juarez, 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...
-
Quality Engineer Ii
hace 4 semanas
Ciudad Juarez, México Johnson & Johnson SA de CV A tiempo completo**QUALITY ENGINEER II** **-** **2306138784W** **Descripción** At **Johnson & Johnson**, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of...
-
Quality Engineer Ii
hace 4 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than...
-
Principal Process Engineering
hace 4 semanas
Ciudad Juarez, México Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Senior Coe Plan Analyst and Leader
hace 1 semana
Ciudad Juarez, México Johnson & Johnson A tiempo completo**At Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than...
-
Manager, Supply Chain Purchasing
hace 4 semanas
Ciudad Juarez, México Cardinal Health A tiempo completo**_What Supply Chain Purchasing contributes to Cardinal Health_** Supply Chain **Purchasing** is responsible for ensuring the right quantity of materials arrive in the right place, at the right time and cost. This job family is accountable for the design and execution of operational supply chain (operations, purchasing, inventory planning, collaborative...
