Regulatory Compliance Specialist for Andean Region

hace 3 semanas

Cali, Valle del Cauca, Colombia Buscojobs Colombia A tiempo completo

About the Role

We are seeking a highly skilled Regulatory Compliance Specialist to join our team in Cali, Colombia. As a key member of our quality assurance department, you will be responsible for ensuring compliance with sanitary regulations for Cosmetic Products, Medical Devices, and Household Hygiene products at our Colombian site.

About Us

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries. We specialize in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world.

Job Summary

The successful candidate will ensure that our Colombian site complies with all sanitary regulations and effectively follows Good Manufacturing Practices (GMP) guidelines applicable to Colgate. This includes leading external audits conducted by regulatory agencies, implementing activities to ensure compliance with sanitary regulations, and actively participating in ensuring compliance with the Quality Master Plan.

Key Responsibilities

  • Provide support and leadership for external audits conducted by INVIMA, SIC, or other health and regulatory authorities, including ESM audits performed by a third party.
  • Conduct Gap Analysis for any updates to sanitary regulations in conjunction with the Regulatory team.
  • Ensure compliance with sanitary standards for Cosmetic Products, Medical Devices, and Household Hygiene products at the Colombian site.
  • Perform Techno-vigilance activities as required by INVIMA.
  • Be responsible for handling complaints and product recalls of medical devices from the market, reporting and following up on adverse incidents with the health authority.
  • Provide technical advice to the legal representative regarding the characteristics of medical devices and ensure compliance with the current regulations concerning their quality.
  • Ensure the technical and regulatory requirements of medical devices are met (by transporters, suppliers, etc.).
  • Ensure medical devices stored meet established conditions, maintain proper documentation and records.
  • Approve procedures related to storage, conditioning, dispatch, and distribution operations of medical devices.
  • Ensure ongoing training of personnel according to needs.
  • Verify that storage, conditioning, and distribution records are completed at each stage of the process.
  • Record, analyze, and manage all adverse events or incidents potentially caused by a medical device.
  • Recommend preventive measures and take immediate action when an event occurs.
  • Guide informants in correctly filling out report forms.
  • Raise awareness among users and potential reporters within the organization about the Techno-vigilance Program, the safety, and proper use of medical devices.
  • Immediately report any serious adverse event or incident to the National Institute of Surveillance of Medicines and Foods (INVIMA), as required by the resolution.
  • Submit periodic reports quarterly to INVIMA or to the Departmental and District Health Secretariats for all non-serious adverse events or incidents, as required by the resolution.
  • Ensure storage conditions for medical devices comply with regulations, and maintain proper reports.

What We Offer

As a Regulatory Compliance Specialist with Colgate-Palmolive, you will have the opportunity to work with a global leader in the consumer products industry. You will receive a competitive salary of $650,000 COP per year, depending on your qualifications and experience. You will also enjoy a range of benefits, including relocation assistance, comprehensive health insurance, and opportunities for professional growth and development.

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