| Overview We're an innovative life sciences startup seeking a Sr Director of Regulatory and Quality Affairs to lead the company’s regulatory strategy and oversee its quality program. This position will lead a team of regulatory and quality professionals, and will be responsible for their development. This role will also be responsible for leading the preparation of U.S. and international regulatory submissions to support global product launches, product development, and post-approval product life cycle. About the Job: - Manage and build a Regulatory and Quality Affairs department, manage timelines, and address gaps in planning and resourcing
- Develop the company’s U.S. and international regulatory strategy and obtain required regulatory clearances for the company’s products
- Be the compliance subject matter expert across a broad range of technical areas, including software as a medical device
- Oversee and manage the implementation and maintenance of the company’s quality program
- Collaborate with cross functional departments to meet established objectives and deadlines
- Assesses and communicates regulatory issues and trends to senior leaders
- Analyze, recommend and implement solutions to regulatory challenges for efficient risk management
- Manage relationships with regulatory agencies across the world
About You: - You have 10+ years of regulatory affairs experience
- You consider yourself to be an expert in US and global medical device regulation, requirements and standards
- You have significant experience serving as a regulatory liaison and developing regulatory strategy - including a broad understanding of international regulations, processes and issues related to medical devices
- You’re flexible and can manage multiple projects with ease
- You love managing and developing teams
- You’re a critical and strategic thinker
- You’re solution oriented
- Regulatory affairs certification (RAC) a plus
- Knowledge of both GCP and GMP regulations
- Masters Degree in a related field
About Us TMRW safeguards the world’s most precious cells for life. The TMRW platform revolutionizes the management, identification, and storage of fertility cells, replacing the manual and analog methods that have remained largely unchanged since IVF was first used in animal husbandry more than 50 years ago. Developed in partnership with leading fertility doctors and embryologists, TMRW’s technology will play a central role in the conception of tens of millions of people in the coming years by reducing the risk of loss or misidentification of the priceless cells used in IVF. Our automation eliminates error-prone manual tasks in the embryology lab, allowing embryologists to focus on the most skilled and technical aspects of their work. The TMRW team includes many of the world’s most celebrated pioneers in clinical medicine, reproductive biology, embryology, and cryogenic biobanking who have synthesized their collective knowledge, vision, and experience in the development of the TMRW platform. We’ve brought together a diverse, cross-disciplinary team to achieve our mission — and we’re always looking for more innovators to join us in creating a better tomorrow. At TMRW we know that cultivating diversity and fostering an inclusive work environment is critical to our impact and success. We offer equal opportunity employment and create an environment where no individual is advantaged or disadvantaged because of their background. |
