Regulatory Affairs Specialist, Consumer Business

hace 7 días

Ciudad de México CDMX 3M A tiempo completo

Job 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 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 to 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
- Ensures compliance with marketer Licenses.

Your Skills and Expertise
- In depth knowledge of health legislation in Mexico for Medical Devices such as LGS, RIS, FEUM Medical Devices Supplement, Oficial Mexican Standar´s NOM-241-SSA1, NOM-137-SSA1, NOM-240-SSA1, and other related.
- Knowledge of LGS regulations regarding advertising
- At least (5) years of experience in direct submissions before COFEPRIS such a modification to the 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 skillsets
- Available to work In México 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

3M 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.

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