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 integral 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.

About The Role

Job Title: Sr. Regulatory Affairs Associate – CONSULTANT

Responsibilities:

• Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. 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
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
• Draft, create or update TDs in collaboration with Platform RA SME.
• 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 in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
• Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s)

• Work with the cross functional teams and Company’s lo

📌 Sr. RA Associate Consultant (México)
🏢 ClinChoice
📍 México