Regulatory Affairs Professional

Job Description

Job Description

$55.00-69.00 / hour

Contract Position

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 :