Regulatory Affairs Specialist
hace 2 meses
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, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You’ll Make in this Role
As a Regulatory Affairs Specialist you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
- Providing general regulatory support for Mexico in reference to medical products sold in the country including:
- Managing medical product licenses in Mexico with COFEPRIS
- Reviewing and approving of medical product labeling, claims and advertisements to ensure alignment with country regulations (e.g. NOM-137-SSA1) and COFEPRIS guidances
- Requesting and managing product technical and legal documents from international and regional counterparts as needed for new product registrations or maintenance of current registrations in country
- Compiling, preparing, and submitting of dossiers for new product registrations/licenses or already established registrations/licenses
- Providing formal and informal assessments of the regulatory pathway for new product introductions or any product changes
- Following business Standard Operating Procedures (SOP’s) regarding specific regulatory activities and tracking with the consultants and distributors
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications
- College Degree in the disciplines of pharmaceutical, chemical, biological, medical, biomedical, biochemical areas or related to Chemistry (BSc) or science career
- Professional License Number and certificate issued
- Written and verbal fluency in both Spanish and English Language
- 5 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures
Additional qualifications that could help you succeed even further in this role include:
- 7 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures
- Regulatory experience in other Latin America countries (outside of Mexico)
- Experience and knowledge with drug regulations in Mexico
- Advanced knowledge in advertising materials aimed to health professionals under COFEPRIS requirements
- Ability to coordinate multitasks
- Able to anticipate regulatory barriers based on advanced knowledge of medical device regulations and uses challenges as learning opportunities
- Demonstrated ability to collaboratively work with teams to accomplish deliverables
Work location:
- Hybrid/Remote Eligible
Solventum es un empleador que ofrece las mismas oportunidades. 3M no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Solventum Global Terms of Use and Privacy Statement
Please access the linked document by clicking
here
,
terms.
-
Senior Regulatory Affairs Specialist
hace 4 meses
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...
-
Sr Regulatory Affairs Specialist
hace 5 meses
03840, Ampliación Nápoles, CDMX, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory...
-
Regulatory Affairs Specialist
hace 2 semanas
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...
-
Regulatory Affairs Specialist
hace 4 meses
Ciudad de México, CDMX Medtronic A tiempo completoAt 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 Specialist
hace 2 meses
Ciudad de México, CDMX Fenixfarma Mexico City, Mexico A tiempo completoRegulatory 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...
-
Regulatory Affairs Specialist
hace 4 meses
Ciudad de México, CDMX Fenixfarma Mexico City, Mexico A tiempo completoRegulatory 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...
-
Senior Specialist Regulatory Affairs
hace 7 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 2 meses
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...
-
Regulatory Affairs Expert
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob 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...
-
Regulatory Affairs Expert
hace 2 meses
Ecatepec de Morelos, México Philips A tiempo completoJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team in Mexico. As a key member of the Regulatory Affairs team, you will be responsible for guiding and supporting businesses, markets, and functions on regulatory needs.
-
Regulatory Affairs Specialist
hace 7 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, Consumer Business
hace 2 meses
Ciudad de México, CDMX 3M A tiempo completoJob 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...
-
Compliance and Regulatory Affairs Specialist
hace 3 días
Ciudad de México, Ciudad de México Moody's Investors Service A tiempo completoAbout the RoleWe are seeking a highly skilled Compliance and Regulatory Affairs Specialist to join our team in Mexico City. This role will be responsible for coordinating compliance and regulatory affairs efforts in Mexico, Peru, Panama, Bolivia, and other jurisdictions.ResponsibilitiesCoordinate compliance and regulatory affairs efforts in Mexico, Peru,...
-
Visionary Regulatory Affairs Strategist
hace 17 horas
Ciudad de México, Ciudad de México Tether Operations Limited A tiempo completoHead of Regulatory Affairs Job DescriptionTether Operations Limited seeks an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo business vertical.
-
Regulatory Affairs Specialist
hace 3 meses
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...
-
Spclst, Regulatory Affairs
hace 3 meses
Ciudad de México, CDMX MSD A tiempo completoEl **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...
-
Regulatory Affairs Specialist
hace 7 días
México ICON A tiempo completo**JR097624** **Regulatory Affairs Specialist** **Site: Mexico, Benito Juarez** At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as...
-
Regulatory Affairs Qro
hace 2 días
México Tata Consultancy Services A tiempo completoWe are a multinational company in the technology consulting and services field, with presence in 46 countries and more than 600,000 employees. Our company is looking for an **Regulatory Affairs**, Functions to join the team: Required Experience: - **COMPLETE YOUR APPLICATION THAT WILL BE SENT BY MESSEGE ON INDEED**: - Regulatory advice to drug development...
-
Regulatory Affairs Specialist
hace 5 meses
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 4 semanas
Ciudad Juárez, México Fenixfarma Mexico City, Mexico A tiempo completoRegulatory 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...