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Regulatory Affairs and Quality Management Lead
2 months ago
About 52North - Creators of Neutrocheck
52North is a leading med-tech company that aims to revolutionize healthcare journeys for people worldwide. As a pioneer in innovative healthcare solutions, we are committed to integrating cutting-edge technology with a human-centered approach to improve patient experiences and set new industry standards.
Our Mission
We are dedicated to helping people live better lives by innovating, collaborating, and leveraging technology that puts people at its core. Whether it's patients, caregivers, doctors, paramedics, or nurses, we strive to make a positive impact on their lives.
Our Flagship Product
Neutrocheck, our flagship product, was selected for the UK government's Innovative Devices Access Pathway (IDAP) pilot programme, providing direct access to regulators and reimbursement authorities. This achievement showcases our commitment to delivering high-quality, innovative solutions that meet the needs of the healthcare industry.
Job Overview
We are seeking a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team. As a key member of our team, you will be responsible for ensuring seamless navigation of the regulatory approval process for our products.
Key Responsibilities
- Develop and de-risk 52North's regulatory strategy for key markets and all potential products.
- Inform and train team members on regulatory requirements and stay up-to-date with regulatory changes globally.
- Ensure device development and validation is conducted and documented in accordance with UK, EU, and FDA regulatory requirements, relevant international standards, and guidelines, as well as 52North's Quality Management System (QMS).
- Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking, ensuring conformance with regulatory requirements.
- Lead communications with regulatory bodies.
- Ensure post-market surveillance activities are conducted in accordance with regulatory requirements.
- Work with regulators, reimbursement bodies, and Notified Bodies to obtain full benefits of the IDAP pilot programme.
Quality Management Responsibilities
- Achieve and maintain full-scope ISO 13485 certification.
- Approve QMS records.
- Deliver on quality objectives.
- Ensure quality training is up-to-date for all staff and that staff understand and follow QMS procedures.
- Ensure suppliers are approved and managed according to our QMS.
- Lead on internal and external audits.
- Transfer from a SharePoint-based QMS to a full eQMS solution to improve efficiency.
- Achieve MDSAP certification to enable access to markets that require it.
- Manage quality personnel as the team grows.
Qualifications and Experience
Essential:
- Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- At least 5 years' experience in regulatory affairs and quality management in medical devices, with at least 1 year in IVDs specifically (EU MDD/MDR, EU IVDD/IVDR, US FDA Class II/III).
- 'Hands-on' experience with the FDA, Notified Bodies, or UK Approved Body, including successful preparation and submission of CE/UKCA marking/FDA approval for a new-to-market Class II/III/Class C/D IVD.
- Experience managing a quality system, ISO compliance, and internal and external audits.
- Excellent organisational, team-working, and communication skills. Proven track record of delivering projects, proactive thinking, designing and implementing processes from scratch, and working collaboratively in a small, fast-paced, and interdisciplinary team. Excellent attention to detail.
Preferred:
- Experience gaining approval for new Software as a Medical Device products and/or connected devices.
- Experience gaining regulatory approval for a self-test.
- Experience as a Quality Management Rep or PRRC.
- Experience with gaining ISO 13485 certification from scratch.
- Experience working in a Notified Body or equivalent.
Benefits
At 52North, we believe that our team should be taken care of both in and outside of the office. We offer a robust benefits package, carefully designed to ensure our team members are supported in all aspects of their lives. Our benefits include:
- Hybrid Working: Enjoy the flexibility of working from home or in our office space.
- Flexible Schedule: We understand that everyone has different needs and rhythms. That is why we offer a flexible work schedule.
- Generous Holiday Allowance: We offer 28 days of paid holiday plus bank holidays every year. On top of that, you will get an extra day off for every two years of service with us.
- Maternity, Paternity, and Adoption Policies: We have comprehensive policies for maternity, paternity, shared parental leave, and adoption to support our team members in these life-changing moments.
- EMI Share Option Scheme: We want our team to be part of our long-term success, so we provide participation in an EMI share option scheme.
- Pension Scheme: We offer a NEST pension scheme with generous employer contributions.
- Health Insurance: Our Vitality health insurance provides generous coverage, including physiotherapy, mental health services, and unlimited virtual GP consultations.
- Dental and Optical Coverage: We cover dental and optical expenses because we know how important complete healthcare is.
- Wellbeing Engagement Programme: We promote a healthy lifestyle by providing a 50% discount on certain gym memberships and other wellness resources.
- Social Activities: We foster a close-knit community with social activities throughout the year and multi-day group retreats.
- Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge, well connected with public transport and Park & Ride. Enjoy free biscuits, cake, tea, and coffee and soak in the beautiful countryside views that our office offers.
