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
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
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.
Telecommuting is allowed.
TMRW’s mission is to safeguard the world’s most precious cells for life. In the coming decades, hundreds of millions of babies will be born through IVF. It’s our job and privilege to make sure that the irreplaceable eggs and embryos, which are at the heart of every IVF birth, are safe, secure, and well cared for. We’ve created the first automated platform that ensures that this system functions flawlessly. At TMRW, each and every one of us is a trustee for someone’s dream of parenthood.
We’re lifelong learners with a unique range of expertises. As a cross-disciplinary team, we bring together innovators with diverse backgrounds, from software development to cryobiology to hospitality, to solve once unsolvable problems. That's why our approach to hiring is less about checking boxes, and more about finding the curious collaborators who are passionate about our mission. In fact, we value new perspectives as part of our belief that what works today can always be improved TMRW.
Service is at the heart of what we do, whether we’re supporting our clinic partners, their patients, or our team. The TMRW sense of hospitality is about anticipating people's needs. To augment our HR team, we h...ave a Head of Coaching who focuses on individual development. Instead of an office manager, we have a Hospitality Manager who makes sure our team is always taken care of. Most of all, we foster a culture of listening and a collective desire to help others be their best selves.