Note: The job is a remote job and is open to candidates in USA. Medasource is recruiting for an unnamed client seeking a Senior Regulatory Affairs Consultant to lead EUDAMED strategy and execution for class III medical devices. The role combines strategic process and governance work with registrations, regulatory documentation and submissions, MDRIM support, and cross-functional coordination.

Responsibilities

• 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

Skills

• Minimum 4+ years hands-on regulatory SME experience in class III medical devices
• Demonstrated experience with EU MDR, US FDA, and global regulatory frameworks
• Experience with Regulatory Information Management (RIM/MDRIM) systems
• 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 from multiple sources
• Able to understand regulatory documentation and manipulate, translate, and apply the content effectively
• Clear, concise communicator with leadership and execution teams
• Ability to ramp quickly with minimal onboarding
• Comfortable operating in a fast-paced, evolving regulatory environment
• EXCEL - theres an elevated excel program that was previously built for the regulatory group, they're going to have to learn to use fast. Simple pivot tables, equations
• Direct EUDAMED experience strongly preferred and considered a differentiator
• Medical device industry background; MedTech Surgery experience strongly preferred
• Prior experience working for a competitor or within a large MedTech organization is a plus
• Prior experience supporting Mentor or Johnson & Johnson MedTech is highly desirable
• Candidates rolling off programs within Surgery or other MedTech regulatory teams are ideal
• Demonstrated ability to deliver results where prior contractors struggled due to lack of independence or slow execution

Benefits

• 401(k) Matching Plan
• Medical, Dental, & Vision Plans
• 6 Paid Holidays
• Medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs.
• A 401k plan that includes a company match and is fully vested after you become eligible
• Paid time off
• Sick time
• Paid company holidays

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