Regulatory Affairs Specialist
hace 4 días
Job Description:
Regulatory Affairs Specialist, Mexico (Solventum)
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 a Regulatory Affairs Specialist 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:
- Providing general regulatory support for Mexico in reference to medical products sold in the country including:
- Managing medical product licenses in Mexico with COFEPRIS
- Reviewing and approving of medical product labeling, claims and advertisements to ensure alignment with country regulations (e.g. NOM-137-SSA1) and COFEPRIS guidances
- Requesting and managing product technical and legal documents from international and regional counterparts as needed for new product registrations or maintenance of current registrations in country
- Compiling, preparing, and submitting of dossiers for new product registrations/licenses or already established registrations/licenses
- Providing formal and informal assessments of the regulatory pathway for new product introductions or any product changes
- Following business Standard Operating Procedures (SOP’s) regarding specific regulatory activities and tracking with the consultants and distributors
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 in the disciplines of pharmaceutical, chemical, biological, medical, biomedical, biochemical areas or related to Chemistry (BSc) or science career
- Professional License Number and certificate issued
- Written and verbal fluency in both Spanish and English Language
- 5 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures
Additional qualifications that could help you succeed even further in this role include:
- 7 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures
- Regulatory experience in other Latin America countries (outside of Mexico)
- Experience and knowledge with drug regulations in Mexico
- Advanced knowledge in advertising materials aimed to health professionals under COFEPRIS requirements
- Ability to coordinate multitasks
- Able to anticipate regulatory barriers based on advanced knowledge of medical device regulations and uses challenges as learning opportunities
- Demonstrated ability to collaboratively work with teams to accomplish deliverables
Work location:
- Hybrid/Remote Eligible
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 is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Solventum Global Terms of Use and Privacy Statement
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