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We’re looking for a creative, collaborative, resourceful, thoughtful, smart, entrepreneurial team member who has a passion for our mission and shares our values. The right candidate will thrive in a fast-paced environment, celebrate winning as a team and be resourceful in finding, creating and implementing solutions. They will balance moving swiftly and thoroughly with ensuring that they are contributing to our collaborative team environment. They will care equally about achieving excellent results and ensuring everyone involved feels a valued part of the team. This person will be a key ambassador for our company.
The successful candidate is a quick learner who will be comfortable in a start-up environment and thrive on finding creative solutions. There is no playbook outside of the mission we share and the values we embrace.
ROLE
This role is responsible for leading the company’s regulatory strategy and oversee its quality program. This position manages the regulatory and quality departments and provides leadership and direction by working cross-functionally with other departments and roles. The Quality & Regulatory Affairs Senior Director will 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. The Quality & Regulatory Affairs Senior Director will also be responsible for managing relationships with regulatory agencies throughout the world. This role is located in our New York office.
This role will be responsible for:
Manage the Quality & Regulatory Affairs departments, 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.
Provide compliance subject matter expertise across a broad range of technical areas, including software as a medical device and quality management systems.
Oversee and manage the implementation and maintenance of the company’s quality program.
Work with multidisciplinary 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.
Reviews promotional material and labeling for compliance with regulatory requirements.
Other duties as assigned.
You must be an enterprising self-starter, comfortable with ambiguity, and focused on flawless execution. You will win by turning ideas into action, strategy into tangible execution that will create value for TMRW and our customers. You will work closely with all of our other teams.
Expertise in US and global medical device regulations, requirements and standards, including ISO 13485, 21 CFR Part 820/801/803/806/807, MDSAP, EU MDR, UKCA, ISO 14971, IEC 61010-1, EN 61326-1, IEC 62304, etc.
Demonstrated excellence in serving as a regulatory liaison and developing regulatory strategy including a broad understanding of international regulations, processes and issues related to medical devices (Class I and Class II)
Flexibility and responsiveness in managing multiple projects
Previous experience managing a team
Evidence of being a critical strategic thinker who is solution oriented
Regulatory affairs certification (RAC) a plus
Knowledge of both GCP and GMP regulations
You are a curious collaborator and strong team player
TMRW Life Science’s mission to safeguard life’s most precious cells. We design technology that provides safety and transparency to modernize and transform IVF. Our platform revolutionizes the management, identification, tracking, storage and care of frozen eggs and embryos used in IVF. Developed in partnership with leading fertility doctors and embryologists, TMRW’s technology will play a central role in the births of tens of millions of people in the coming years by setting a new standard of care in the IVF industry. Our team includes many pioneering leaders 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’re committed to bringing 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.
