Regulatory Affairs Specialist: Product Compliance Expert

hace 1 semana


Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo

**Job Overview**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at CooperVision. This role will be responsible for ensuring compliance with regulatory requirements for our medical products.

Salary: $80,000 - $110,000 per year, depending on experience and location.

Job Description:

The ideal candidate will have a strong background in Regulatory Affairs and Quality Assurance, with a minimum of 5 years' experience in the field. They will be responsible for gathering and assembling information for submission of new registrations, variations, and renewal registrations of CooperVision products. This includes preparing regulatory labeling requirements specifications for new and modified products, reviewing product labeling to ensure compliance, and communicating with local competent authorities and trade associations as needed.

Key Responsibilities:

  • Gather and assemble information for submission of new registrations, variations, and renewal registrations of CooperVision products
  • Prepare regulatory labeling requirements specifications for new and modified products
  • Review product labeling to ensure compliance
  • Communicate with local competent authorities and trade associations as needed
  • Support quality activities according to demand: product complaints, non-conformities, environmental control, product reception, training, nationalization, internal and external audits

Required Skills and Qualifications:

  • Strong background in Regulatory Affairs and Quality Assurance
  • Minimum of 5 years' experience in the field
  • Graduated in pharmacy or another health area
  • Advanced knowledge in Microsoft Office Suite including Word, PowerPoint, and Excel
  • Ability to understand, read, write, and speak English (advanced)

Benefits:

  • A competitive salary range of $80,000 - $110,000 per year
  • Ongoing professional development opportunities
  • A collaborative and dynamic work environment

Others:

Please note that this is a challenging but rewarding role for someone who is passionate about Regulatory Affairs and Quality Assurance. If you are interested in this opportunity, please submit your application.



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