18 feb
3M Group
Xico
Regulatory Affairs Specialist, Consumer Business Group
Regulatory Affairs Specialist, Consumer Business GroupApply remote type Hybrid locations MX, Mexico City time type Full time posted on Posted 4 Days Ago job requisition id R01141483.
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 the achievement of business objectives.
The impact you will make in this role: Prepare Technical Documentation for Consumer Health productsAssure that all device listings, establishment licenses, and registrations for Consumer Health products are accurate and up to dateAdvise on new regulatory strategies and regulatory changesReview product labeling and claims for compliance with applicable regulationsRepresent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management ProjectsBusiness and Distribution regulatory assistance as requiredInterface with local agency COFEPRISParticipate and provide support to Mexican RegulatoryEnsure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance/vigilanceSupport other LATAM area consultancy agreements and resourcing plans as requiredEnsure compliance with marketer LicensesYour 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 other related regulationsKnowledge of LGS regulations regarding advertisingAt least 5 years of experience in direct submissions before COFEPRIS such as modifications to registration conditions, obtaining new registrations, electronic renewals, and advertising permits for web pages and medical devicesClassification and regulatory requirements for low-risk devices, Class I, Class II, sterile productsAbility to communicate effectively with the Health AuthorityExperience as Sanitary Responsible preferredBachelor's degree or higher (completed and verified prior to start)Combined experience in RegulatoryAdvanced English speaking skillsAvailable to work in Mexico CitySupporting 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.
Except it is not magic; it is the right science, applied in the right way by the people of 3M.
Here,
your ideas help shape everyday lives around the globe.
Here, you matter.
You inspire.
Challenge.
Create.
Thrive.
Here, you go.
Apply now and discover inspired opportunities!
3M is an equal opportunity employer.
3M will not discriminate against any job applicant on the basis of race, color, age, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or veteran status.
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.
3M Global Terms of Use and Privacy Statement: Carefully read these Terms of Use before using this website.
Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here, select the country where you are applying for employment, and review.
Before submitting your application, you will be asked to confirm your agreement with the terms.
About UsAt 3M we apply science in collaborative ways to improve lives daily as our employees connect with customers all around the world.
Learn more about 3M's creative solutions to global challenges at www.3M.com or on Twitter @3M or @3MNews.
#J-18808-Ljbffr
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.