Sr. RA Associate Consultant

Collaborate with the regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other regulatory requirements. Draft and update TDs in collaboration with Platform RA SME, and perform Quality Control checks to ensure completeness and correctness of documents. Communicate with cross-functional teams and local affiliates to obtain necessary supporting documents and respond to inquiries.

Bachelor’s degree in life sciences preferred. Minimum of 2 years of experience in Regulatory Affairs focused on EU MDR. Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory. Strong written and verbal English communication skills required.

12 months contract with the possibility of extension. Opportunity to work directly for a single sponsor while benefiting from the security and career opportunities of a global CRO.