Medtech Regulatory Affairs Lead — Eu Compliance

Job Overview
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Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.

Essential Functions

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• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand‑alone projects
  
• Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
  
• Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
  
• Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
  
• Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
  
• Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
  
• Manage project timelines, deliverables, budgets, and out‑of‑scope activities to ensure successful project execution and financial performance
  
• Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
  
• Support business development activities, including travelling to and participating in bid defense meetings and client presentations
  
• Contribute to the development, revision, and review of regulatory and cross‑functional Standard Operating Procedures (SOPs)
  
• Support global, regional, and cross‑functional regulatory initiatives and process improvement activities
  
• Remain current with regulatory intelligence, evolving regulations, and industry best practices
  
• Perform additional duties as assigned to support business and departmental objectives
  

Qualifications

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• Bachelor's Degree in Life Sciences or a related discipline required
  
• Master's Degree in Life Sciences or a related discipline preferred
  

Experience

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• Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
  
• Minimum of 2 to 3 years of hands‑on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)
  
• Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance
  
• Experience interacting with Reporting Member States (RMS) and other European regulatory authorities
  
• Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
  
• Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements
  
• Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities
  
• Experience with combination product trials is advantageous
  
• Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments
  
• Ability to independently manage multiple projects and priorities while meeting challenging timelines
  
• Strong project leadership and stakeholder management skills
  
• Excellent written and verbal communication skills, including preparation of high‑quality regulatory documents and client‑facing presentations
  
• Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities
  
• Proficiency in Microsoft Office and relevant regulatory systems and publishing tools
  
• Applicable certifications and licenses as required by local regulations and business needs
  
• Willingness to support cross‑functional and global initiatives as required
  

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