Sr. Regulatory Affairs Associate- CONSULTANT

hace 2 días

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 Sr. 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: Sr. Regulatory Affairs Associate- CONSULTANT

Location: Mexico - Remote

Responsibilities:

  • Actively collaborate with the client's regulatory project team to collect all necessary TF/DD documents for resubmission. The high-level activities may include but are not limited to:
    • Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements
    • Identification of applicable regulatory requirements, standards, guidance, and submission requirements relevant to the project
    • Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files.
    • Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders.
    • Perform Quality Control checks per client's procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc.
    • Verify TF/DD documents are approved and contain the most recent revision(s)
  • Work with the local affiliates to respond to queries and obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects)
  • Notify and coordinate with the leadership of any health authority related questions
  • Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
  • Attend meetings and communicate with the project team as appropriate
  • Communicate daily or weekly with regulatory management team regarding project status and deliverables

Minimum Requirements:

  • Bachelor's degree (life sciences preferred)
  • Minimum of 1 year of working experience in Medical Device Regulatory Affairs/ training in Regulatory Affairs focused on EU MDR
  • Knowledge of FDA Medical Device regulations, ISO13485, EU MDD/MDR
  • 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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