Regulatory Affairs Specialist, Export Countries

**Job Description**:
Regulatory Affairs Specialist, Export Countries (Solventum)

Mexico City

3M Health Care is now Solventum

At 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’ll Make in this Role

As Regulatory Affairs Latam for Export Countries 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 be responsible to provide all regulatory support to Consultants and Distributors in Export Countries, in order to assure the compliance with the local regulatory legislation and the Company requirements.- You will be the regulatory contact between the Consultants in Latam export countries (Costa Rica, Panama, Honduras, Guatemala, etc) and 3M Regulatory team in the Headquarter and in the different Sources of Supply in order to provide on the regulatory information required locally to maintain and update sanitary registers, registers new products, provide documents and certificates, etc.- You will be responsible of manage regulatory documents and provide these to Consultants and Distributors: Technical and Legal Documents of registration and bids activities such as Certificate of Foreign Government, Certificates of Free Sale, Good Manufacturing, etc.- You will be responsible of the compile, preparation, and support the submission of dossiers with regulatory purposes in Latam countries assigned for submission of Medical Devices and Drugs- You will carry out the development of Standard Operation Procedures (SOP’s) for Regulatory Activities and Tracking with the Consultants and Distributors.- Others: Approvals of Stocks Keeping Units (SKU’s) for Supply and Demand Activities. Labelling review and approvals and Advertising review for Marketing campaigns.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications- College: Degree on pharmaceutical, medical or biomedical- Certificate issued is required.- English, Advanced or Medium Level to perform in a fluid way all the activities assigned as part of a bilingual community across LATAM and International stakeholders (basic requirement as part of the job profile to fulfil to this position; skill to demonstrate during the interview)- 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- Capacity to negotiate with internal stakeholders and external stakeholders like the Consultants, Distributors and local Regulatory Agencies.- 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 and /or DrugsAdditional qualifications that could help you succeed even further in this role include:
- 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- Strongest-proactive team player- Focuses work team to accomplish key strategic goals- Positively contributes to and supports team efforts and objectives.

Work location:

- Hybrid Eligible

Relocation Assistance: May be authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum 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 Global Terms of Use and Privacy Statement

Please access the linked