Lead - Regulatory Affairs (EU MDR)

Roles & Responsibilities
• Collaborate with client regulatory project teams to collect and compile Technical File (TF) / Design Dossier (DD) documents in compliance with EU MDR (2017/745) and MDCG guidance
• Identify applicable regulatory requirements, harmonized standards, and submission expectations
• Review, obtain, and combine TF/DD documents from PLM or regulatory systems into Adobe PDF files
• Create and upload bookmarks and indexes into PLM via Change Orders
• Perform Quality Control checks for completeness, correct pagination, and document accuracy
• Coordinate with cross-functional teams and affiliates to obtain legal documents (CFG, CFS, etc.)
• Respond to regulatory inquiries from affiliates and health authorities
• Represent Regulatory Affairs in project team meetings and provide regulatory updates
• Communicate project status and deliverables to regulatory management
• Support additional regulatory activities as assigned

Qualification
• Bachelor of Pharmacy, Master of Pharmacy
• Bachelor’s degree (Life Sciences preferred)

Experience
• 8–10 years of experience in Regulatory Affairs
• Strong experience with EU MDR (2017/745) requirements
• Knowledge of ISO 13485 and FDA Medical Device regulations mandatory

Skills
• In-depth understanding of EU MDR and MDCG guidance documents
• Experience in Technical File and Design Dossier compilation
• Familiarity with PLM systems and document management processes
• Strong QC review and document control expertise
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Excellent written and verbal English communication skills
• Strong stakeholder coordination and project management abilities

About the Company
ClinChoice is a global Contract Research Organization (CRO) providing regulatory, clinical, and consulting services to pharmaceutical, biotechnology, and medical device companies, supporting compliance with international regulatory frameworks across global markets.