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Head of Regulatory Affairs and Quality Management
2 months ago
Crowned 'MedTech Company of the Year' in the Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys for all people across the world.
Our mission is to empower individuals to live better lives by innovating, collaborating, and leveraging cutting-edge technology that prioritizes human-centered approaches. We integrate technology with a focus on people who will engage with it, including those living with disease, caregivers, doctors, paramedics, and nurses. By combining cutting-edge technology with a human-centered approach, we're committed to transforming patient experiences and setting new industry standards.
We are at an exciting and fast-paced stage of the company's growth and are seeking a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team and ensure seamless navigation of the regulatory approval process. If you are passionate about gaining regulatory approval for state-of-the-art technology to make healthcare systems more efficient and transform the lives of patients worldwide, we encourage you to apply.
Key ResponsibilitiesAs the Person Responsible for Regulatory Compliance (PRRC), you will be responsible for:
- Developing and de-risking 52North's regulatory strategy for key markets for all potential 52North products.
- Informing and training team members on regulatory requirements and staying up-to-date with regulatory changes globally.
- Ensuring device development and validation is conducted and documented in accordance with UK, EU, and FDA regulatory requirements, relevant international standards, and guidelines, and 52North's Quality Management System (QMS).
- Leading the preparation of regulatory submissions, including for FDA approval, UKCA, and CE marking, and ensuring conformance with regulatory requirements.
- Leading on communications with regulatory bodies.
- Once on-market, ensuring post-market surveillance activities are conducted in accordance with regulatory requirements.
In time, you would also take on quality management responsibilities as the Management Quality Representative, becoming responsible for all aspects of the QMS, including:
- Achieving and maintaining full-scope ISO 13485 certification.
- Approving QMS records.
- Delivering on quality objectives.
- Ensuring quality training is up-to-date for all staff and that staff understand and follow QMS procedures.
- Ensuring suppliers are approved and managed according to our QMS.
- Leading on internal and external audits.
- Transferring from a SharePoint-based QMS to a full eQMS solution to improve efficiency.
- Managing quality personnel as the team grows.
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).
- Experience managing a quality system, ISO compliance, and internal and external audits, 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 ISO 13485 certification from scratch.
- Experience working in a Notified Body or equivalent.
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.
- 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.
