Senior Regulatory Affairs Consultant – EU MDR (Remote)

Remote; San Francisco (CA); À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

ClinChoice is a global full-service CRO seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract with potential extension to join one of our client teams.

This client-facing role requires independence, high-trust communication with the client's counterparts, and the ability to work with regulatory project teams to manage TDs and submissions per EU MDR and related global requirements. You will draft, review, and QC regulatory documents, coordinate with cross-functional

Qualifications

• Bachelor’s degree in life sciences
• Minimum of 2 years of experience in Regulatory Affairs focused on EU MDR
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations
• Proficiency in Microsoft Office
• Strong communication and organizational skills

Responsabilités

• Collaborate with regulatory project team to review, update, and create Technical Documents (TDs) per EU MDR and other global requirements
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
• Draft, create or update TDs in collaboration with Platform RA SME
• QC TD documents for completeness, pagination, and revision status
• Coordinate with cross-functional teams to obtain necessary supporting documents
• Respond to inquiries from local affiliates and coordinate with management on regulatory questions

Connaissances

Regulatory Affairs

EU MDR knowledge

FDA Medical Devices knowledge

Microsoft Office

Formation

Bachelor’s degree in life sciences

Outils

Adobe PDF

Description du poste

ClinChoice is a global full-service CRO seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract with potential extension to join one of our client teams.

This client-facing role requires independence, high-trust communication with the client's counterparts, and the ability to work with regulatory project teams to manage TDs and submissions per EU MDR and related global requirements. You will draft, review, and QC regulatory documents, coordinate with cross-functional