Regulatory Affairs Professional

Siemens Healthineers

About The Position

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.

Requirements

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 demonstrating favorable outcomes such as regulatory approvals) a must
Proficiency in ISO 13485, 21CFR820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745 is a must
Experience in medium to high-risk devices with, along with De Novo or PMA applications, and demonstrated approvals are a must
Experience in generating, updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports is a must
Experience with authoring and managing Technical Files and Design Dossiers conforming with Europe’s Medical Device Regulation is a must
Experience in project management and associated project management tools (e.g. Microsoft Project) is a must
Experience with FDA inspection (QSIT) and Notified Body audits is required
Ability and willingness to work in a lean, fast-paced environment
Willing to travel up to 10%

Nice To Haves

Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America) are ideal
Knowledge and experience in clinical affairs including IDE submissions are ideal
Experience with complex electromechanical, software controlled robotic systems, AI, SaMD, neuro devices is ideal
Experience with FDA BIMO inspection is ideal
RAC-devices certificate preferred

Responsibilities

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)
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