Regulatory Affairs Associate

hace 10 horas

Ciudad de México, Ciudad de México ClinChoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.  

Job Title: Regulatory Affairs Associate - CONSULTANT

Location: Mexico; Remote

Responsibilities:

  • Support planning and project management across Regulatory Affairs, serving as the key liaison with global stakeholders
  • Leverage data analytics, metrics, and insights to organize regulatory information, demonstrate value, and enable informed decision-making across the business
  • Collect, review, and upload product, licensed product and license data in databases (e.g., UDI, eligibility, etc.)
  • Review, execute and drive eligibility releases as per required procedures
  • Review, track and monitor critical Notified Body mailbox and invoices
  • On a project/product basis, facilitate change orders for DEC/DoC/DD and other documents in the PLM system(s), and assist with strategy creation, follow-up on local assessments and creation of relevant documentation (e.g., letters to file)
  • Maintain/update in all relevant databases and sources (e.g., GRID for document self-serve)
  • On a project basis, monitor, track and execute regulatory operational processes as required
  • Perform other tasks as required

Minimum Requirements:

  • Bachelor's degree (life sciences preferred)
    • Knowledge of EU MDD/MDR, ISO13485, US FDA QSR
    • Proven ability to manage and track multiple regulatory projects and timelines
    • Strong data analytics skills with experience using metrics, dashboards, and reporting to drive decisions and demonstrate value
    • Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
    • Strong proficiency in written and verbal English communication is required.

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR, ISO 13485, US FDA QSR

#LI-PB1 #LI-REMOTE

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