Position Summary
My client is seeking a highly experienced Clinical/Regulatory Director who will play a crucial role in shaping their clinical and regulatory strategies. The ideal candidate will be responsible for developing and executing programs that align with the company's vision, ensuring the successful execution of clinical studies, and managing submissions for the extension of indications for our products. This individual must represent the company with confidence and credibility, demonstrating a hands-on approach to achieving our goals.
Responsibilities Develop and implement a comprehensive clinical and regulatory strategy that aligns with the company's vision and long-term goals.Design, manage, and oversee the execution of clinical studies related to FastWire Technology, ensuring they meet the highest standards of quality and regulatory compliance.Prepare and tailor regulatory submissions for both the USA and EU markets to achieve necessary approvals.Ensure adherence to relevant regulatory standards, including CFR 21, ISO 13485, 60601, and 62304.Collaborate effectively with senior stakeholders across various departments, including Marketing, R&D, and Medical Affairs, to ensure successful product development and regulatory compliance.Monitor and oversee the execution of clinical trials, ensuring all activities are conducted in accordance with regulatory requirements and Good Clinical Practice (GCP) guidelines.Act as the primary contact with regulatory authorities, managing communications and submissions.Responsible for Regulatory Compliance (PRRC) as per article 15 of MDR 2017/745.Lead or participate in cross-functional project teams, ensuring regulatory requirements are met on time and within budget. Knowledge and Skills Required Proven senior experience in clinical and regulatory affairs, particularly in the field of intravascular devices.In-depth knowledge of regulatory standards, including CFR 21, ISO 13485, 60601, and 62304.Direct experience in the design, development, and execution of clinical studies for intravascular devices.Demonstrated success in the oversight and design of regulatory studies aimed at extending device indications.Extensive experience preparing submissions tailored for regulatory approvals in the USA and EU.Strong interpersonal skills with the ability to engage and collaborate with senior stakeholders across multiple business units.A meticulous eye for detail and a proactive, hands-on approach to task execution and problem-solving.
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