Regulatory Affairs Specialist

THE RIGHT CANDIDATE

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 seek first to understand, work with the current team to get up to speed, utilize and synthesize work that has already been done to get up to speed quickly on the business. They must 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 ensuring that TMRW’s medical devices meet applicable standards and global regulations including 21 CFR Part 820/801/803/806/807, ISO 13485:2016, ISO 14971:2019, EU MDR 2017/745 and other MDSAP markets. You will have the opportunity to collaborate with cross-functional teams including Design Engineering, Systems Engineering, Product, Scientific Affairs and Marketing to maintain adherence to the Quality Management throughout the product lifecycle (e.g., concept, development, manufacturing, marketing). This role is based in our New York, NY office.

• Evaluates proposed changes for potential regulatory filing in accordance with FDA, MDR and MDD requirements. Proposes plans/strategizes (if appropriate) for changes that do not require submissions and ensures the Technical Documentation is up to date.
• Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities (FDA or Notified Bodies) to update product information and/or instructions for use to reflect current state of product knowledge.
• Updates and/or identifies the need for new regulatory processes and SOPs, ensuring that departmental SOPs are developed/updated in accordance with applicable regulatory requirements including MDSAP markets and the EU market (MDR).
• Identify, monitor, and submit applicable reports (e.g., Serious Adverse Events, Field Safety Corrective Actions) or notifications (e.g., changes in manufacturing, relevant supplier/subcontractors) to regulatory authorities in accordance with MDR and FDA requirements.
• Ensures post market surveillance is performed and kept up to date in accordance with MDR.
• Manages and maintains Regulatory registrations including FURLS, EUDAMED, UDI database and other country specific registration databases,
• Reviews promotional material and labeling for compliance with regulatory requirements.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Assists in the development of regulatory strategy and updates product strategy across internal teams based upon regulatory changes.

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 our Regulatory and Quality team.

WHAT YOU'LL NEED TO SUCCEED

• Bachelor’s degree or equivalent work experience
• 3+ years related work experience in regulatory affairs required
• Experience in:
  • 21 CFR Part 820/801/803/806/807
  • EU MDR 2017/745
  • ISO 13485:2016
  • ISO 14971:2007/2019
  • and all other MDSAP markets
• FDA Class I and II medical device experience required
• Medical device software experience helpful
• You are a curious collaborator and strong team player

ABOUT US

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.

At TMRW, we know that cultivating diversity and fostering an inclusive work environment is critical to our impact and success. We create an environment where no individual is advantaged or disadvantaged because of their background. We offer equal opportunity employment regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, marital status, or protected veteran status.

With a commitment to maintaining a bias-free environment where harassment is prohibited, we respect cultural diversity and comply with the laws of the places we operate. We expect our business partners, suppliers, clients, and team members to uphold these commitments.

We look for people who share our values. They are our promise to each other and the guideposts for our day-to-day work.

Our TMRW values:

Integrity is our non-negotiable.

Excellence is our standard.

Collaboration is how we win.

Trailblazing is our spirit.

Service is our passion.

Care is at the heart of everything we do.

Compensation Range: $100,000-$150,000. This is the pay range the Company believes it will pay for this position at the time of this. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. For this role, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off.

Experience

• FDA Class I and II medical device experience required
• 3 year(s): Related work experience in regulatory affairs required

• Experience in: 21 CFR Part 820/801/803/806/807 EU MDR 2017/745 ISO 13485:2016 ISO 14971:2007/2019 and all other MDSAP markets
• Medical device software experience helpful

Education

• Bachelors or better