Regulatory Affairs Associate - CONSULTANT Mexico

Regulatory Affairs Associate - CONSULTANT

Mexico

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 : MexicoRemote

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
• 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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