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Quality and Compliance Manager
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 strive to help people live better lives by innovating, collaborating, and leveraging technology that prioritizes the needs of those who will engage with it. Our team is dedicated to navigating the regulatory approval process seamlessly, ensuring that our products meet the highest standards of quality and compliance.
Key Responsibilities
- Regulatory Strategy and Compliance
- Develop and implement a comprehensive regulatory strategy for key markets, ensuring compliance with UK, EU, and FDA regulations.
- Stay up-to-date with regulatory changes and inform team members on relevant requirements.
- Quality Management and Assurance
- Ensure device development and validation meet UK, EU, and FDA regulatory requirements, as well as international standards and guidelines.
- Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking.
- Communicate with regulatory bodies and ensure post-market surveillance activities comply with regulatory requirements.
- Quality Management Representative
- Take on quality management responsibilities, ensuring the Quality Management System (QMS) is maintained and improved.
- Achieve and maintain full-scope ISO13485 certification.
- Approve QMS records, deliver on quality objectives, and ensure quality training is up-to-date for all staff.
- Manage suppliers, lead internal and external audits, and transfer to a full eQMS solution to improve efficiency.
- Achieve MDSAP certification to enable access to markets that require it.
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 organizational, team-working, and communication skills, with a 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.
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 ISO13485 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.
