Head of Quality and Regulatory Affairs
3 weeks ago
About 52North
52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. 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.
As a key member of our team, you will be responsible for ensuring we navigate the regulatory approval process seamlessly. You will be responsible for building out and de-risking 52North's regulatory strategy for key markets for all potential 52North products.
Key Responsibilities:
- 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.
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.
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.
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