Regulatory Affairs Specialist

hace 1 día


Bogotá, Bogotá D.E., Colombia Werfenlife Sa. A tiempo completo
Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife Sa. This is an exciting opportunity for a motivated and experienced professional to support the implementation and execution of regulatory and quality plans.

Key Responsibilities:

  • Support RAQA management with a business focus, ensuring compliance with regulatory record management processes.
  • Lead and manage non-conformities, follow-up plans for CAPAs, document tracking, and control in SAP.
  • Prepare and update quality agreements, manage regulatory and quality databases, and follow-up on regulatory processes with the factory.
  • Review registration requests received in detail and provide appropriate responses and support to stakeholders.

Requirements:

  • Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
  • Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
  • Intermediate English language skills.
  • Knowledge of ISO 13485 and/or ISO 9001-2015.

Compensation:

The estimated salary for this position is approximately $80,000 - $110,000 per year, depending on location and experience.

About Werfenlife Sa:

Werfenlife Sa is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We offer a dynamic work environment and opportunities for career growth and development.



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