Regulatory Affairs Specialist
hace 2 días
Solventum is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements for our medical devices.
Key Responsibilities- Review and support business-related to marketing and advertising for healthcare products.
- Ensure that labeling and claims of packaging materials for health and consumer products are in full compliance with the Official Mexican Standard (NOM-137-SSA1 current edition).
- Control requests and reception of technical dossiers (FULL-STED) from international and regional counterparts within Solventum Headquarters.
- Manage regulatory documents such as certificates of foreign government, certificates of free sale, good manufacturing practices certifications, technical and distribution agreements, etc.
- Compile, prepare, and submit dossiers for registration purposes under regulatory affairs coordinator's supervision for submission of medical devices: Class IA (low risk), I, and II products according to the check list established by COFEPRIS current edition.
- Carry out the development of standard operating procedures (SOPs) for regulatory activities within healthcare and consumer products scope.
- Approvals of stocks keeping units (SKU's) for supply and demand activities into the healthcare business unit and advertising review for marketing campaigns.
- College degree in pharmaceutical, chemical, biological, medical, biomedical, biochemical areas, or related to chemistry (BSc) or science career.
- Professional license number and certificate issued is required.
- English, advanced level to perform fluidly in all assigned activities as regulatory affairs Jr. coordinator as part of a bilingual community across LATAM.
- Advanced knowledge in regulatory affairs and documentation activities for medical devices. Minimum 5 years of experience.
- Advanced knowledge in advertising materials aimed at health professionals under COFEPRIS requirements for digital media.
- Good understanding of the regulatory background in market authorization application in medical devices licenses maintenance and life cycle product under COFEPRIS requirements.
- Hybrid work environment.
- Relocation assistance not authorized.
- Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).
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