About 52North:

52North is a medical technology company on a mission to make urgent care safer and better. Backed by leading healthcare-linked funds in the US and UK, and awarded breakthrough status for its first product Neutrocheck® by the UK Government in 2024, 52North is building an offering of in vitro diagnostic and digital solutions to transform patient journeys in the most critical of times. We’re a high-performing, award-winning team with deep ambition and we value excellence, execution, and exemplary teamwork.

About the opportunity:

Shape the future of quality & regulatory excellence! We are seeking a Senior Quality & Regulatory Specialist to drive design control, compliance, and innovation. In this role, you’ll be at the heart of product development, ensuring seamless regulatory alignment while collaborating with cross-functional teams. From risk management to verification and validation, your expertise will play a crucial role in delivering industry-leading solutions. If you're passionate about precision, compliance, and driving meaningful impact, this is your chance to thrive in a dynamic, forward-thinking environment.

Key Responsibilities:

• Ensure product development aligns with IVD and SaMD regulatory requirements, maintaining compliance with industry standard
• Own and oversee the creation, maintenance, and review of design history files (DHF), device master records (DMR), and risk management documentation (ISO 14971)
• Oversee testing protocols, ensuring that design outputs meet intended use requirements and regulatory guidelines.
• Monitor and assess regulatory changes, providing impact analysis and integrating necessary updates within 52North.
• Develop and execute the regulatory and quality strategy for 52Ns portfolio, including Regulatory submissions as necessary.

Essential Experience:

• Regulatory Expertise – Proven experience with regulatory submissions and compliance for IVD and SaMD products in UK, EU, and US markets.
• Design Control Mastery – Hands-on experience managing Design History Files (DHF), risk assessments (ISO 14971), and verification & validation (V&V) processes.
• Quality Management Systems (QMS) – Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other regulatory frameworks governing medical technology.
• Software & IVD Development Knowledge – Familiarity with Software Lifecycle processes, IEC 62304, and IVDs in regulated environments.

Benefits:

At 52North, we offer a comprehensive benefits package to support our team members. Benefits include:

• Being part of an award-winning team redefining healthcare globally.
• Competitive compensation and equity package, and benefits including private healthcare, and dental.
• A collaborative, agile, and mission-driven work culture.
• Flexibility to work in a hybrid format.
• Opportunity to shape the commercial future of an exciting and innovative med-tech platform, ready to improve healthcare for millions.

Equal Opportunities:

52North is committed to providing equal employment opportunities to all employees and applicants without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristics protected by law. Our dedication to diversity and inclusion ensures that every individual has an equal opportunity to succeed based on their qualifications, skills, and merit.