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Regulatory Affairs Specialist

hace 2 meses

Ciudad de México, Ciudad de México QuidelOrtho A tiempo completo
About the Opportunity

QuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.

Our company culture prioritizes employee happiness, inspiration, and engagement, and we strive to build meaningful connections with each other. We believe that employee happiness and business success are linked, and we're committed to transforming the power of diagnostics into a healthier future for all.

Key Responsibilities
  • Prepare and submit regulatory documents, including submission dossiers and technical modification dossiers, to ensure compliance with regulatory requirements.
  • Coordinate with cross-functional teams to ensure timely and accurate submission of regulatory documents.
  • Monitor and follow up on regulatory submissions, notifications, and CAPAs to ensure compliance and resolution.
  • Support the importation process by communicating changes, approvals, and label changes to stakeholders.
  • Provide regulatory support to sales representatives, marketing teams, and other departments as needed.
  • Perform other work-related duties as assigned.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, or Biochemistry.
  • At least 3 years of experience in quality and/or regulatory affairs, preferably in the pharmaceutical or life science industry.
  • Advanced knowledge of MS Office and regulatory databases.
  • Fluent in English and willingness to travel up to 10% of the time.