Regulatory Affairs Specialist
hace 2 meses
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But itâs not just what we do, itâs who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customersâ needs. Itâs what inspires us to create meaningful solutions â the kind that make a real difference â when it matters most.
The world and our customersâ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thatâs why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Guide & support Businesses, Markets and supporting functions of regulatory needs of the Mexico market for medical and non-medical products/solutions under your responsibility including the development of regulatory strategies for new and existing products/solutions, execution of regulatory submissions and engagement with external associations.
You are responsible for
Serving as the subject matter expert on regulatory affairs between manufacturers and internal and external stakeholders in Mexico
Communicating on time and accurate Mexico specific regulatory requirements and advise  business partners/product design teams of regulatory strategy and requirements
Implementing global regulatory strategies and roadmaps through understanding competitive market landscape and product marketing strategies
Preparing regulatory submissions for new products/solutions, product changes, and re-registrations as required for Mexico and LATAM countries.
Planning and maintain registration information and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Being the subject matter expert and key point of contact for communication with Regulatory Affairs activities related to Mexico regulators, trade associations and Competent Authorities
Maintaining and organizing appropriate regulatory records to demonstrate compliance with applicable regulations in Mexico and LATAM.
Supporting development of regulatory plans, risk assessments and required activities to meet regulatory requirements and product registrations to maintain compliance
Acting as advisor cross- functionally to meet the schedules and/or solve technical questions
You are a part of
The Regulatory Affairs team of Latin America, where you will influence and lead the Regulatory Affairs efforts with the business.
To succeed in this role, youâll need a customer-first attitude and the following
Ability to work in a matrix organization with multiple stakeholders internal and external to ensure time to market.
Proven successful record of accomplishment in Regulatory Affairs in Medical Devices and in Mexico with mandatory with at least 5 years of operational Regulatory Affairs experience
Experience with interacting with local Trade-Associations, Competent Authorities, Notified Bodies
Strong communication skills and influencing skills
Organized detailed oriented and strong decision making skills
Advanced English level
Bachelor's degree (Technical/Engineering or Medical, Biomedical)
Work autonomously with established procedures and practices
In return, we offer you
In order to develop your full potential, we will offer you the flexibility, encouragement, and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way since together we can improve the world.Â
Work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.Â
Company relocation benefits will not be provided for this position.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart â which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home â for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyoneâs in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnât office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?
Working at Philips is more than a job. Itâs a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
#LI-PH1Â Â
-
Regulatory Affairs Specialist
hace 3 semanas
Huixquilucan de Degollado, México Philips A tiempo completo**Job Title**: Regulatory Affairs Specialist Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique...
-
Regulatory Affairs Specialist
hace 2 meses
Huixquilucan de Degollado, México Philips A tiempo completoJOB DESCRIPTION Job Title Regulatory Affairs Specialist Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are....
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob SummaryThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo**Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...
-
Senior Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, CDMX Icon plc A tiempo completoSenior 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...
-
Regulatory Affairs Specialist LATAM
hace 4 días
Ciudad de México, Ciudad de México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the LATAM region.Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions,...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Philips Iberica SAU A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting our businesses, markets, and supporting functions in the Mexico market to ensure compliance with regulatory requirements.Key...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completoJob Title: Regulatory Affairs CoordinatorCompany: Fenixfarma Mexico City, MexicoJob Summary:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...
-
Senior Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Icon plc A tiempo completoJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory Document Preparation...
-
Senior Specialist Regulatory Affairs
hace 3 meses
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...
-
Regulatory Affairs Specialist
hace 4 días
Victoria de Durango, Durango, México Novartis Farmacéutica A tiempo completoAbout the Role**Job Summary:**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novartis Farmacéutica. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our pharmaceutical products.Key Responsibilities:Regulatory Compliance: Ensure that all regulatory submissions, including...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México ICON Plc A tiempo completoJob SummaryICON Plc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory ComplianceLead the preparation, submission, and...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México QuidelOrtho A tiempo completoAbout the OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.Our company culture prioritizes employee happiness,...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Kenvue A tiempo completoAbout KenvueKenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.Job SummaryWe are seeking a highly...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México MMATISS A tiempo completoKey Responsibilities:As a Regulatory Affairs Coordinator at MMATISS, you will be responsible for ensuring compliance with local regulations by performing submissions and tracking the progress of approvals. You will implement regulatory processes to avoid warnings or rejections, including obtaining protocol, site, marketing, and importation/exportation...
-
Regulatory Affairs Specialist
hace 3 meses
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...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México GSK A tiempo completoRegulatory Affairs Specialist Role at GSKThis position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.Key...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Procter & Gamble A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts, maintaining existing product licenses for medicinal products or Food Supplements, and...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products in Mexico and Central America.Key ResponsibilitiesRegulatory Guidance and Support: Provide expert...
-
Regulatory Affairs Director
hace 5 días
Naucalpan de Juárez, México Merck Group A tiempo completoAbout the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merck Group. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with local regulations and guidelines for our pharmaceutical products and medical devices.Key Responsibilities:Develop and implement regulatory strategies...
