Regulatory Affairs Specialist, Consumer Business Group.

Detalles de la oferta

.3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking and take risks on new ideas. Here, you can apply your talent in bold ways that matter.Job Description:Collaborate with innovative 3Mers around the world.As Regulatory Affairs Specialist, you will play a key role in coordinating regulatory strategy for Mexico in the division of Consumer Health Group. In this role, you will provide support and expertise as part of the Regulatory organization using knowledge of Mexican regulatory requirements and paths to support achievement of business objectives.The impact you will make in this role:Prepare Technical Documentation for Consumer Health products.Assure that all device listings, establishment licenses, and registrations for Consumer Health products are accurate and up to date.Advise on new regulatory strategies and regulatory changes.Review product labeling and claims for compliance with applicable regulations.Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects.Business and Distribution regulatory assistance as required.Interface with local agency COFEPRIS.Participate and provide support to Mexican Regulatory.Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance/vigilance.Support other LATAM area consultancy agreements and resourcing plans as required.Ensure compliance with marketer licenses.Your Skills and Expertise:To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications:In-depth knowledge of health legislation in Mexico for Medical Devices such as LGS, RIS, FEUM Medical Devices Supplement, Official Mexican Standards NOM-241-SSA1, NOM-137-SSA1, NOM-240-SSA1, and others.Knowledge of LGS regulations regarding advertising.At least 5 years of experience in direct submissions before COFEPRIS such as modification to registration conditions, obtaining new registrations, electronic renewals, and advertising permits for web pages and medical devices.Classification and regulatory requirements for low-risk devices, Class I, Class II, sterile products.Ability to communicate effectively with the Health Authority.Experience as Sanitary Responsible preferred.Bachelor's degree or higher (completed and verified prior to start).Combined experience in Regulatory.Advanced English speaking skills.Available to work in Mexico City.Supporting Your Well-being:3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.Imagine your future in 3M:At 3M, inspiration happens daily. Here, science is how the magic happens


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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