Regulatory Affairs Expert for Medical Products in Mexico

hace 7 días


Xico, México Solventum A tiempo completo

**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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