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Head of QARA

2 months ago

Cambridge Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

About 52North

Crowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a med-tech company aiming to reinvent healthcare journeys for all people across the world.

Our mission is to help people live better lives, and we do this through innovating, collaborating and using cutting-edge technology that centre around the people who will engage with it: whether they are people living with disease, care givers, doctors, paramedics or nurses. By integrating cutting-edge technology with a human-centred approach, we're dedicated to revolutionising patient experiences and setting new industry standards.

Our flagship product, Neutrocheck, was selected as one of a handful of technologies globally for the UK government’s first Innovative Devices Access Pathway (IDAP) pilot programme, providing direct and regular access to regulators and reimbursement authorities.

We are at an exciting and fast-paced stage of the company’s growth and are looking for a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team and ensure we navigate the regulatory approval process seamlessly. Apply now 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 around the world.

Position Overview

Key Responsibilities:

As Person Responsible for Regulatory Compliance (PRRC) you will be responsible for:

  • Building out 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 QMS.
  • Leading 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.
  • Working with regulators, reimbursement bodies and Notified Bodies, as required, in order to obtain full benefit of the IDAP pilot programme.

In time, you would also take on quality management responsibilities as Management Quality Representative, becoming responsible for all aspects of the QMS, including:

  • Achieving and maintaining full-scope ISO13485 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 full eQMS solution to improve efficiency.
  • Achieving MDSAP certification to enable access to markets that require it.
  • Managing 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 ISO13485 certification from scratch
  • Experience working in a Notified Body or equivalent

52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristics protected by law.

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 beautiful 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.

Join us at 52North and enjoy these benefits as you work in an environment that fosters growth and encourages work-life balance.