Senior Regulatory Affairs Specialist

hace 1 día


Xico, México Solventum A tiempo completo

About the Role

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As a Senior Regulatory Affairs Specialist at Solventum, you will play a critical role in ensuring compliance with regulatory requirements for medical products in Mexico. Your expertise will be essential in managing product licenses, reviewing labeling and claims, and assessing the regulatory pathway for new product introductions or changes.

Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with COFEPRIS guidelines and Mexican regulations.
  • Manage medical product licenses and registrations, including compilation and submission of dossiers.
  • Review and approve medical product labeling, claims, and advertisements to ensure alignment with country regulations.
  • Collaborate with international and regional counterparts to request and manage product technical and legal documents.
  • Provide formal and informal assessments of the regulatory pathway for new product introductions or any product changes.
  • Follow business Standard Operating Procedures (SOPs) regarding specific regulatory activities and track progress with consultants and distributors.

Requirements

  • A College Degree in pharmaceutical, chemical, biological, medical, biomedical, biochemical areas, or related fields.
  • Professional License Number and certificate issued.
  • Written and verbal fluency in both Spanish and English Language.
  • No less than 5 years of experience in medical product regulatory affairs space, specifically as it relates to Mexico and COFEPRIS requirements & procedures.

Additional Requirements

  • 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 challenges as learning opportunities.
  • Demonstrated ability to collaboratively work with teams to accomplish deliverables.

What We Offer

  • A hybrid/remote work arrangement that allows for flexibility and work-life balance.
  • A competitive salary ranging from $80,000 to $120,000 per year, depending on experience and qualifications.
  • The opportunity to work with a leading company in the industry and contribute to its growth and success.


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