What are the responsibilities and job description for the Regulatory Affairs Specialist position at CONFLUX SYSTEMS?
As a Regulatory Affairs Specialist Consultant you will be responsible for:
• 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.
Required skills to have for the success of this role:
• 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 favourable 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.
• Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America) are ideal.
• Experience in project management and associated project management tools (e.g., Microsoft Project) is a must.
• 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 inspection (QSIT) and Notified Body audits is required.
• Experience with FDA BIMO inspection is ideal.
• RAC-devices certificate preferred.
• Ability and willingness to work in a lean, fast-paced environment.
• Willing to travel up to 5%.