Senior Associate - Regulatory Affairs (Reg Ops EU MDR)

Roles & Responsibilities
• Collaborate closely with client regulatory project teams to identify, collect, and maintain Technical File (TF) and Design Dossier (DD) documents in compliance with EU MDR (2017/745) and MDCG guidance
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
• Review, compile, and consolidate TF/DD documentation from PLM or other regulatory systems into Adobe PDF formats
• Create and upload bookmarks and indexes of regulatory documents in PLM via Change Orders
• Perform Quality Control checks as per client SOPs, training, and checklists (completeness, pagination, missing or blank pages)
• Coordinate with cross-functional teams and affiliates to obtain legal and regulatory documents such as CFG, CFS, and supporting submissions
• Respond to queries from local affiliates and manage health authority–related requests
• Represent Regulatory Affairs on cross-functional project teams and communicate regulatory requirements effectively
• Participate in project meetings and provide regular status updates to regulatory management
• Support additional regulatory operations activities as assigned

Qualifications
• Bachelor’s degree in Life Sciences or related discipline

Experience
• 4–6 years of hands-on experience in Regulatory Affairs with strong focus on EU MDR and Regulatory Operations

Skills
• In-depth knowledge of EU MDR (2017/745), ISO 13485, and FDA medical device regulations
• Experience in Technical File / Design Dossier preparation and maintenance
• Strong document management and quality control skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Excellent written and verbal English communication skills
• Ability to work independently in a remote, cross-functional, and global environment

About the Organization
ClinChoice is a global regulatory, clinical, and biometrics services partner to leading pharmaceutical, medical device, and consumer health companies. With operations across the US, UK, Europe, Asia, and India, ClinChoice delivers high-quality, data-driven regulatory and clinical solutions, supporting global compliance, innovation, and patient safety while offering flexible work models and long-term career growth.