Regulatory Affairs Professional

Overview

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

We are currently looking for an ambitious Principal Regulatory Affairs Specialist to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance, and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

• Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia).
• In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDE), and pre-market notifications, such as De Novo.
• Support and manage interactions with regulatory bodies (e.g., FDA, Notified Body).
• Support Clinical Affairs (Research) in Clinical Evaluation Reports, Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures.
• Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs.
• Support clinical affairs and clinical operations as needed (i.e., periodic reporting of safety to regulatory agencies).
• Support document change control activities that require regulatory approval.
• Review validation protocols and reports to support regulatory submissions.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
• Ensure compliance with regulatory agencies and all applicable standards worldwide for legacy and new products.
• Work on complex challenges that require in depth knowledge of regulatory principles and practices.
• Other duties as assigned.

• Bachelor’s degree in a scientific discipline required, Master’s degree or higher preferred.
• Minimum of 15+ years’ experience in strategic Clinical and Regulatory Affairs tactical executions, including authoring regulatory submissions and achieving approvals.
• Proficiency in ISO 13485, 21
  
  CFR
  820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745.
• Experience with medium to high-risk devices with De Novo or PMA applications and demonstrated approvals.
• Experience in generating, updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports.
• Experience with authoring and managing Technical Files and Design Dossiers conforming with Europe’s Medical Device Regulation.
• Proficiency and experience in rest of world regulatory submissions requirements (e.g., Asia, South America) are ideal.
• Experience in project management and related tools (e.g., Microsoft Project).
• Knowledge in clinical affairs including IDE submissions is ideal.
• Experience with complex electromechanical, software controlled robotic systems, AI, SaMD, neuro devices is ideal.
• Experience with FDA inspection (QSIT) and Notified Body audits is required.
• RAC-devices certificate preferred.
• Ability and willingness to work in a lean, fast-paced environment.
• Willing to travel up to 10%.

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

When you…