Early
Quality and Regulatory Manager
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Quality & Regulatory Affairs Manager
At Early we’re building a new way to detect serious disease far earlier by making it super easy from anyone’s home.
No needles. No expensive clinics. No sending samples to a lab. We bring the lab into your home with powerful science that is magically simple to use.
We’re looking for someone exceptional to help us take our mission to millions of people.
The Quality & Regulatory Affairs Manager will play a pivotal role at Early Health, taking ownership of the quality and regulatory systems that underpin the development and delivery of our IVD medical devices.
This is a hands-on role with significant responsibility and autonomy. You will lead the development and improvement of Early’s Quality Management System (QMS), ensuring compliance with ISO 13485 and applicable regulatory requirements while building processes that are practical and appropriate for a fast-moving organisation.
You will work closely with colleagues across science, engineering, software and data science, embedding quality into the way we develop our products rather than treating it as a standalone function. A key part of the role will be ensuring that team members understand their responsibilities within the QMS and are appropriately trained to work within it.
Alongside quality management, you will lead and support regulatory activities across the product lifecycle, including preparation of technical documentation, performance evaluation activities and regulatory submissions. You will help ensure Early remains responsive to the evolving regulatory landscape.
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Key Responsibilities
- Serve as Early’s Person Responsible for Regulatory Compliance (PRRC) to ensure compliance with EU IVDR.
- Design quality procedures and review existing procedures to ensure all processes meet safety, legal and other national or international standards.
- Own, maintain and continuously improve Early’s QMS, including document control, design and development activities, internal audits, CAPA, management reviews, and quality records, and supplier management.
- Work closely with product development teams to ensure quality and regulatory requirements are incorporated throughout the design and development lifecycle.
- Plan and lead regulatory submissions and communications with notified bodies and competent authorities, including submissions for performance evaluation studies.
- Support regulatory activities associated with performance evaluation studies, including relevant submissions, documentation and regulatory reporting.
- Ensure appropriate application of relevant standards and regulations, including ISO 13485, ISO 14971, IEC 62304 and IEC 62366, across science, engineering, software and data activities.
- Promote a strong quality culture across the organisation through training, guidance and close collaboration with multidisciplinary teams.
- Demonstrate hands-on, proactive approach, supporting cross-functional teams as needed in a dynamic startup environment.
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Ideal Candidate
- A degree in a relevant bioengineering subject and at least 3 years’ experience in Regulatory Affairs and/or Quality Assurance for medical devices or IVDs.
- Direct experience of coordinating and communicating with notified bodies and competent authorities.
- Strong working knowledge of ISO 13485 QMS implementation, maintenance, and improvement.
- In-depth knowledge of EU IVDR, IEC 62304 and ISO 14971.
- Hands-on experience in technical documentation, regulatory submissions, and document control.
- Experience managing approved suppliers, contractors, and consultants within a regulated environment.
- Excellent communication skills and ability to work autonomously in a distributed team.
Please note we are not a remote working or hybrid company. We are bringing very advanced technology into people’s homes but we can’t build this from our own ones. Please don’t apply if you want to work from yours.
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