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Mexico Regulatory Affairs Lead

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**Job Description**:Regulatory Affairs LeadMexico City3M Health Care is now SolventumAt 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- 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 ExpertiseTo 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 MediaAdditional 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:- HybridRelocation Assistance: Not authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-beingSolventum 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 postin