Director of Regulatory Affairs

Qualifications

• Extensive experience in regulatory and clinical affairs within the medical device industry
• Solid case experience of achieving FDA PMA approval
• Experience overseeing and working with CROs
• You bring a resilient, can-do attitude and demonstrate persistence when facing challenges
• With strong stakeholder management skills, you have a proven ability to influence and build relationships across all levels of the organization and beyond
• You thrive in collaborative environments, working effectively with both internal and external stakeholders to drive successful outcomes
• Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task

Responsibilities

• Your expertise will ensure that our team fully understands and complies with all necessary processes, ultimately guiding us to achieve successful FDA approval
• Achieving the company goals for FDA PMA approvals
• Supporting and leading the process through regulatory discussions & regulatory adherence with FDA and regulatory partner in the US
• Driving and overseeing CRO activities to align with company objectives
• Overseeing clinical requirements for ongoing clinical studies in the US as part of the FDA application process
• Ensuring clinical data integrity and making sure study timelines are consistently met
• Building and maintaining relationships with key industry stakeholders to support our regulatory and clinical initiatives
• You will collaborate extensively with our Clinical Affairs Director, Chief Quality & Regulatory Affairs Officer and Senior Advisor to ensure seamless coordination and success in our regulatory endeavors in the US