Today, billions of lives are cut short by illness. Unfulfilled dreams, uncompleted work, time spent with loved ones — think what we could collectively achieve if we all lived longer. Huma partners with scientists, technologists, healthcare, and pharma professionals to understand, treat, and ultimately prevent ill health. Giving knowledge and power to those with medical conditions, while saving clinicians time, energy, and valuable resources.
Huma has already seen incredible success in the U.K. and European markets, and are now excited to expand to the US. By joining Huma US, you’ll play an integral role in creatively building an organization committed to helping people live their longest, fullest lives.
This role leading the US Regulatory & Compliance team will require a combination of regulatory, business and information skills to enable innovative products to be developed and deployed while ensuring required legislation is met. As the founding member of the US Regulatory & Compliance team, you will have an input into new and existing projects, as well as advise on changing regulations and their impact on projects. You will be working with a growing team to help shape regulatory and information governance pathways for the registration of products in the US, while working in a fast-changing and exciting environment. This is an unique opportunity for someone with an entrepreneurial mind-set to contribute to the tremendous growth of a truly mission driven health-tech company.
What you will be doing
- Create and maintain regulatory documentation, prepare regulatory submissions (such as technical files), and manage the regulatory submission process for US submissions
- Contribute to strategies and submissions for complex products to gain approvals for commercial distribution and clinical research
- Define requirements and the processes for preparing technical and regulatory documentation and submissions
- Ensure our processes are compliant with relevant industry standards and medical devices requirements
- Work with the Huma team to develop world-class approaches to clinical trials and evaluation, providing guidance and support including design verification, pre-clinical, and clinical studies
- Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, and development
- Act as liaison between Clinical, Research, Partner, Trial Unit, Engineering, Product, Design and Legal Teams
- Maintain knowledge on changing regulations and standards that are relevant to Huma
Your skills & capabilities
- Significant experience working in healthcare with software medical devices
- Awareness of changing US regulations and standards that are relevant to medical devices
- Experience writing and preparing submissions to the FDA
- Confident in providing advice to teams conducting clinical evaluations and clinical investigations
- Experience supporting product development teams by collating and keeping up to date product technical documentation, regulatory documentation and declarations of conformity
- Excellent at writing easy-to-follow policies and procedures
- Highly analytical, data driven, and numerically literate
- Naturally driven to be innovative, think outside the box, deliver on time and in line with commitments
- Passionate and conversant on digital healthcare trends and healthtech sector
Playing to your strengths
- Self-starter - to be able to hit the ground running and help create the future of healthcare
- Agile thinker - comfortable adjusting to a fluid business environment where rapid change is the norm
- Resilient - show adaptability and willingness to work across teams, contributing wherever you can
- Visionary - imagine what is possible, and have the courage to take risks that will drive our business forward
- Industry expert - well networked, and able to leverage contacts to improve internal capabilities & teach best practices
- Humility - you’re never done learning
We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We are an environment where everyone has the opportunity to do their best work; come and join us.
If there are any adjustments we can make for our process to be more inclusive, please get in touch.