Mexico Regulatory Affairs Lead

Gracias por tu interés en trabajar para nuestra empresa. Contar con el talento adecuado es crucial para lograr nuestros objetivos. El 01 de abril de 2024, 3M Healthcare experimentó una separación corporativa que condujo a la creación de una nueva empresa denominada Solventum. Aún, estamos en el proceso de actualizar nuestra página de carreras y los documentos de nuestros aplicantes, los cuales actualmente tienen la marca 3M. Mientras tanto, nuestra Política de Privacidad aquí: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continúa aplicándose a cualquier información personal que envíe, y los puestos de la marca 3M que figuran en nuestra Página de Empleo son para puestos de Solventum. Igual que con 3M, en Solventum todos los solicitantes calificados serán considerados para un empleo sin importar su raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional, discapacidad o condición de veterano protegido.

Job Description

Regulatory Affairs Lead

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 will make in this role

Role

As a Regulatory Affairs Lead, you will play a crucial role in ensuring compliance of our medical devices with all national regulations. You will compile, prepare, and submit dossiers for registration with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). This pivotal role supports our product registration activities as we transition into a standalone Healthcare company. We are at the forefront of providing innovative medical and dental solutions to patients across Mexico. The ideal candidate for this position will be detail-oriented, have a strong understanding of medical device regulations, and possess the ability to manage multiple projects efficiently. As Regulatory Affairs Lead 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 review and supporting to business related to Marketing Advertising for Health Care Products
• You will ensure that the labeling and claims of packaging materials for Health and Consumer Products are in full Compliance according the Official Mexican Standard (NOM-137-SSA1 current edition)
• You will be responsible of the control request and reception of Technical Dossiers (FULL-STED) from International and Regional counterparts within Solventum Headquarter
• You will be responsible of manage regulatory documents since maintenance: Technical and Legal Documents of registration activities such as Certificate of Foreign Government, Certificates of Free Sale, Good Manufacturing Practices Certifications, Technical and Distribution Agreements, etc.
• You will be responsible of the compile, preparation, and submission of dossiers with registration purposes under Regulatory Affairs Coordinators supervision for submission of Medical Devices: Class IA (low risk), I and II products according the Check List established by COFEPRIS current edition
• You will carry out the development of Standard Operation Procedures (SOP’s) for Regulatory Activities with Health Care and Consumer Products scope
• Others: Approvals of Stocks Keeping Units (SKU’s) for Supply and Demand Activities into the Health Care Business Unit 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, chemical, biological, medical, biomedical, biochemical areas or related to Chemistry (BSc) or science career
• Professional License Number and certificate issued is required.
• English, Advanced Level to perform in a fluid way all the activities assigned as Regulatory Affairs Jr. Coordinator as part of a bilingual community across LATAM.
• Advanced knowledge in Regulatory Affairs and Documentation Activities for Medical Devices. Minimum 8 years of experience.
• Advanced knowledge in Advertising Materials aimed to Health Professionals under COFEPRIS requirements for Digital Media
• Good understanding of the regulatory background in market authorization application in Medical Devices licenses maintenance and Life Cycle Product under COFEPRIS requirements.
  
  

Additional qualifications that could help you succeed even further in this role include:

• 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
• Negotiate with stakeholders mainly for the following connectivities: External: Certified Translator (Perito traductor), Notary Office, COFEPRIS, and Trade Associations of Medical Devices, Third Party Reviewer by COFEPRIS
• Analytic capacity, sense of urgency and prioritizing ability; proactivity and high effectiveness for the follow-up to fulfill the assigned activities.
• 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
• Focuses work team to accomplish key strategic goals
• Positively contributes to and supports team efforts and objectives.
  
  

Work location:

• Hybrid
  
  

Relocation Assistance: Not 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 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.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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