Job Type






Consumer Health Care Regional Regulatory Affairs Lead, LATAM San Luis Potosí

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3M San Luis Potosí San Luis Potosi Mexico

3 months ago

Position Description

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers.

The Impact You’ll Make in this Role

As Regulatory Affairs person 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 to 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 3M 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, 3M requires (at a minimum) the following qualifications:
• Degree on pharmaceutical, chemical, biological, medical, biomedical, biochemical areas or related to Chemistry (BSc) or science career
• Professional License Number and certificate issued
• Advanced English Level
• Analytic capacity, sense of urgency and prioritizing ability; proactivity and high effectiveness for the follow-up to fulfill the assigned activities.
• Advanced knowledge in Regulatory Affairs and Documentation Activities for Medical Devices.
• 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 multitaskand responsible of assuming delegation of activities.
• Advanced skilled technical person / team required for product registrations
• 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 network: Internal: Direct connectivity and teamwork with their peers and regulatory affairs manager as well as with Country Business Manager of Health Care Business Group. External: Certified Translator (Perito traductor), Notary Office, COFEPRIS, and Trade Associations of Medical Devices, Third Party Reviewer by COFEPRIS (Terceros Autorizados por COFEPRIS
• 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
• Strongest-proactive team player
• Focuses work team to accomplish key strategic goals
• Positively contributes to and supports team efforts and objectives.

Travel: May include up to 15% domestic/international

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.

Resources for You

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at

San Luis Potosí San Luis Potosi Mexico

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