Regulatory Affairs Expert for Medical Products in Mexico
hace 7 días
**Medical Product Regulatory Specialist Role**
Solventum, a pioneer in healthcare innovation, is seeking an experienced Regulatory Affairs Specialist to join our team in Mexico.
This exciting role offers the opportunity to collaborate with a diverse group of professionals and make a meaningful impact on the development and approval of medical products sold in the country.
Responsibilities:
We are looking for a highly skilled individual with expertise in regulatory affairs to provide support for the management of medical product licenses in Mexico. Key responsibilities include:
- Managing medical product licenses with COFEPRIS, ensuring compliance with national regulations (e.g., NOM-137-SSA1) and guidelines.
- Reviewing and approving medical product labeling, claims, and advertisements to guarantee alignment with country regulations.
- Requesting and managing product technical and legal documents from international and regional counterparts for new product registrations or maintenance of current registrations.
- Compiling, preparing, and submitting dossiers for new product registrations/licenses or 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 consultants and distributors.
Requirements:
To excel in this role, candidates must possess:
- A college degree in pharmaceutical, chemical, biological, medical, biomedical, biochemical areas, or related fields (BSc).
- Professional License Number and certificate issued.
- Fluency in both Spanish and English languages, written and verbal.
- At least 5 years of experience in medical product regulatory affairs, specifically related to Mexico and COFEPRIS requirements & procedures.
Desirable Qualifications:
Candidates with additional qualifications, such as:
- 7 years of experience in medical product regulatory affairs, specifically related 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 at health professionals under COFEPRIS requirements.
- Ability to coordinate multiple tasks.
- 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.
The estimated salary range for this position is between $60,000 - $90,000 per year, depending on experience and qualifications.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.
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