Regulatory Affairs Associate - CONSULTANT

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: Must be available 2-3hrs during PST (Pacific Standard Time) business hours

Responsibilities:

• 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)
  • Basic knowledge of US FDA QSR, 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, Regulatory Compliance, EU MDD/MDR

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