Regulatory Affairs Specialist, Export Countries
hace 6 meses
**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 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 Regulatory Affairs Latam for Export Countries 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:
- You will be responsible to provide all regulatory support to Consultants and Distributors in Export Countries, in order to assure the compliance with the local regulatory legislation and the Company requirements.- You will be the regulatory contact between the Consultants in Latam export countries (Costa Rica, Panama, Honduras, Guatemala, etc) and 3M Regulatory team in the Headquarter and in the different Sources of Supply in order to provide on the regulatory information required locally to maintain and update sanitary registers, registers new products, provide documents and certificates, etc.- You will be responsible of manage regulatory documents and provide these to Consultants and Distributors: Technical and Legal Documents of registration and bids activities such as Certificate of Foreign Government, Certificates of Free Sale, Good Manufacturing, etc.- You will be responsible of the compile, preparation, and support the submission of dossiers with regulatory purposes in Latam countries assigned for submission of Medical Devices and Drugs- You will carry out the development of Standard Operation Procedures (SOP’s) for Regulatory Activities and Tracking with the Consultants and Distributors.- Others: Approvals of Stocks Keeping Units (SKU’s) for Supply and Demand Activities. Labelling review and approvals and Advertising review for Marketing campaigns.
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 on pharmaceutical, medical or biomedical- Certificate issued is required.- English, Advanced or Medium Level to perform in a fluid way all the activities assigned as part of a bilingual community across LATAM and International stakeholders (basic requirement as part of the job profile to fulfil to this position; skill to demonstrate during the interview)- Ability to coordinate multitasks- Responsible of assuming delegation of activities and take leadership when it's needed assigned by the Direct Supervisor/or next highest level into RAQ organization- Capacity to negotiate with internal stakeholders and external stakeholders like the Consultants, Distributors and local Regulatory Agencies.- Analytic capacity, sense of urgency and prioritizing ability; proactivity and high effectiveness for the follow-up to fulfill the assigned activities- Advanced knowledge in Regulatory Affairs and Documentation Activities for Medical Devices and /or DrugsAdditional qualifications that could help you succeed even further in this role include:
- Advanced skilled technical person / team required for product registrations- Strategy independence for making regulatory basic decisions for delegated tasks- Able to anticipate regulatory barriers based on their advanced knowledge of medical device regulations and uses challenges as learning opportunities to avoid making the same mistake twice- Strongest-proactive team player- Focuses work team to accomplish key strategic goals- Positively contributes to and supports team efforts and objectives.
Work location:
- Hybrid Eligible
Relocation Assistance: May be authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
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 Global Terms of Use and Privacy Statement
Please access the linked
-
Regulatory Affairs Specialist
hace 6 meses
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 Jr Specialist
hace 6 meses
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 -...
-
Regulatory Affairs Specialist
hace 6 meses
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 Associate Consultant
hace 6 meses
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**: -...
-
Manager Regulatory Affairs Affiliate
hace 6 meses
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 Manager Jr
hace 7 meses
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...
-
Export Specialist
hace 6 meses
Tlahuac, México InnovaRH A tiempo completoWe invite you to join our team as **EXPORT SPECIALIST** **Requirements**: - Bachelor’s Degree in International Trade - 3 years of experience in a similar position - Conversational Business English (EXAM REQUIRED) - Knowledge of Customs Regulations (pedimentos, certificates, incoterms, etc.) - Commercial and Logistics Analysis Skills - Availability to...
-
Regulatory Affairs Analyst
hace 6 meses
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...
-
Mgr, Regulatory Intelligence
hace 8 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **JOB SUMMARY**: The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities...
-
Ssu & Regulatory Specialist with Experience in
hace 6 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **SSU & Regulatory Specialist with experience in clinical trials-Client Based Mexico-CDMX** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...
-
Import/export
hace 6 meses
Tlahuac, México Eaton A tiempo completo**What you’ll do**: The major roles of the Import & Export Analyst are import and export the material for the plant Cuautitlan - Eaton assurance the deliveries on time through all the customs and to maintain the follow up of each shipment and update compliance documents to reflect current regulatory requirements and procedures. As a result of their work,...
-
Regulatory Engagement Lead
hace 6 meses
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...
-
Import/export Analyst
hace 6 meses
Tlahuac, México Cooper Wiring Devices, S.A. de C.V. A tiempo completoThe major roles of the Import & Export Analyst are import and export the material for the plant Cuautitlan - Eaton assurance the deliveries on time through all the customs and to maintain the follow up of each shipment and update compliance documents to reflect current regulatory requirements and procedures. As a result of their work, the Customs Coordinator...
-
Sr Associate Regulatory Affairs
hace 6 meses
Tlahuac, México Amgen A tiempo completo**HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Ssu & Regulatory Specialist with Experience in
hace 6 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **SSU & Regulatory Specialist with experience in clinical trials focus logistics-Client Based Mexico-CDMX** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...
-
Regulatory Affairs Specialist
hace 6 meses
Tlahuac, México ICON A tiempo completoAs a (job title) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: **You are**: **Why ICON?** Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a...
-
Healthcare Compliance Sr Specialist
hace 6 meses
Tlahuac, México Johnson & Johnson A tiempo completoDiversity, Equity & 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 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...
-
Import/export Specialist
hace 6 meses
Tlahuac, México NCR A tiempo completoAbout NCR VOYIX NCR VOYIX Corporation (NYSE: VYX) is a leading global provider of digital commerce solutions for the retail, restaurant and banking industries. NCR VOYIX is headquartered in Atlanta, Georgia, with approximately 16,000 employees in 35 countries across the globe. For nearly 140 years, we have been the global leader in consumer transaction...
-
Start-up & Regulatory Specialist
hace 6 meses
Tlahuac, México Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Managing Counsel
hace 6 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Managing Counsel** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team,...