Regulatory Affairs Director jobs in New York

 Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company below: www.cresilon.com  

The Director of Regulatory Affairs (RA) is a functional leader of Cresilon. The Director of RA oversees the following functions: Regulatory Strategy, Regulatory Operations, and Regulatory Intelligence.  The Director of RA is responsible for developing and executing Cresilon’s regulatory strategies across the life-cycle of Cresilon’s products. The RA Director is well versed in US, EU, and international medical device regulations and develops the least-burdensome commercialization approaches within a highly cross-functional environment. The RA Director adopts and maintains a culture of excellence and quality in all aspects of their job function. The RA Director works in a highly-regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon. 

Responsibilities:

• Lead the creation and execution of proactive regulatory strategies for product development, approval, and commercialization. 
• Ensure all regulatory strategies have cross-functional buy-in, are fluid, and robust, as appropriate. 
• Monitor, interpret, and communicate changes in regulatory requirements to internal teams. Ensure that all products and processes comply with relevant regulations and guidelines. 
• Serve as the primary point of contact for interactions with regulatory agencies and authorities.  
• Prepare and submit regulatory submissions, including new applications, product registrations, and other required documentation. 

• Collaborate with Quality teams to ensure compliance with regulatory standards, including but not limited to GMP, GLP, and GCP, as applicable. 
• Lead regulatory submission deliverables.  
• Foster strong relationships with regulatory agencies, representing the company during regulatory inspections, meetings, and inquiries, as appropriate. 
• Collaborate with the Quality team to establish and maintain a culture of quality and compliance within the organization. 
• Oversee the creation, maintenance, and organization of regulatory documentation. 

• Lead and mentor a team of regulatory affairs professionals, fostering their growth and development. 
• Stay informed about evolving regulatory trends and changes, providing insights and recommendations to the executive team. 
• Act as Official Correspondent to Regulatory Authorities (e.g., FDA) on behalf of Cresilon, Inc. 
• Submit Marketing Applications to Regulatory Authorities on behalf of Cresilon, Inc. 
• Represent Cresilon, Inc to Regulatory Authorities, both in writing and in person.