EUDAMED Regulatory Specialist

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EUDAMED Regulatory Specialist

Remote Role

Our client is seeking a Regulatory Affairs Specialist with deep expertise in EUDAMED and EU MDR compliance within the medical device sector. This role is responsible for both strategic and tactical regulatory activities, including designing and implementing sustainable EUDAMED strategies, establishing governance and data ownership, and integrating processes to ensure compliance. The specialist will assess and improve current regulatory processes, provide actionable recommendations, and deliver strategic regulatory insights to support leadership and align with global compliance standards.

Key responsibilities include managing EUDAMED registrations, maintaining and updating technical documentation, supporting MDR Information Management (MDRIM) activities, and collaborating with cross-functional teams. The ideal candidate will have hands‑on regulatory experience in medical devices, strong knowledge of EU MDR, US FDA, and global regulatory frameworks, and the ability to synthesize complex regulatory data and communicate effectively with both leadership and execution teams.

Experience with Med Tech Surgery and large Med Tech organizations is highly desirable. This role will support both strategy and execution as EUDAMED requirements evolve toward 2026 and will operate under a Statement of Work (SOW) model, with budget allocation supported by Surgery once finalized.

• Design and implement a sustainable EUDAMED strategy, including governance, data ownership, and process integration
• Assess current-state EUDAMED and MDR processes and provide actionable recommendations for improvement
• Support leadership with strategic regulatory insight aligned to MDR, EUDAMED, and global compliance expectations
• Partner with Senior Regulatory leadership to ensure alignment with Mentor and Surgery-wide regulatory objectives
• Manage initial and ongoing EUDAMED registrations, including legal manufacturer and obligation assessments
• Conduct detailed reviews of regulatory documentation (DOCs) to identify updates, newly signed documents, and gaps
• Translate regulatory documentation into structured, usable data for EUDAMED and MDRIM systems
• Support MDR Information Management (MDRIM) activities and execution rollout
• Maintain and update technical documentation to support EU MDR and global regulatory compliance
• Collaborate with internal teams supporting scope list development and execution activities
• Coordinate international registrations and work with global affiliates
• Work cross-functionally with R&D, Quality, and Regulatory teams
• Ensure end-to-end regulatory responsibility, including CMC considerations (as applicable), regulatory submissions and maintenance, US and CE submissions for new product development and approvals, and lifecycle management of marketed products
• Operate independently in a fast-paced, evolving regulatory environment
• Communicate clearly and effectively with leadership and execution teams
• Collaborate with stakeholders including Regulatory leadership, CSS support, and cross-functional partners

• Minimum 2+ years hands‑on regulatory SME experience in medical devices
• Demonstrated experience with EU MDR, US FDA, and global regulatory frameworks
• Direct EUDAMED experience strongly preferred and considered a differentiator
• Experience with Regulatory Information Management (RIM/MDRIM) systems
• Medical device industry background;
  Med Tech Surgery experience strongly preferred
• Prior experience working for a competitor or within a large Med Tech organization is a plus
• Proven cross‑functional collaboration with R&D, Quality, and Regulatory teams
• Experience supporting international registrations and coordinating with global affiliates
• End‑to‑end regulatory responsibility, including CMC considerations, regulatory submissions and maintenance, US and CE submissions, and lifecycle management of marketed products
• Strong independent thinker and problem solver; able to assess ambiguity and propose solutions without heavy direction
• Strategic mindset with tactical execution ability
• Highly organized with strong attention to detail
• Proficient in Excel and synthesizing data…