Head of Regulatory Affairs and Quality Management

2 months ago

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

About 52North

52North, the creators of Neutrocheck®, is a leading med-tech company that aims to revolutionize healthcare journeys for people worldwide. As a pioneer in innovative healthcare solutions, we strive to make a positive impact on people's lives through cutting-edge technology and a human-centered approach.

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 individuals living with disease, caregivers, doctors, paramedics, or nurses, our goal is to transform patient experiences and set new industry standards.

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 highlights our commitment to developing 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 the Person Responsible for Regulatory Compliance (PRRC), you will play a crucial role in ensuring seamless regulatory approval processes for our products.

Key Responsibilities:

  • Regulatory Strategy: Develop and de-risk 52North's regulatory strategy for key markets, covering all potential products.
  • Regulatory Training: Inform and train team members on regulatory requirements, ensuring they stay up-to-date with global regulatory changes.
  • Device Development: Ensure device development and validation align with UK, EU, and FDA regulatory requirements, relevant international standards, and 52North's Quality Management System (QMS).
  • Regulatory Submissions: Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking, ensuring conformance with regulatory requirements.
  • Regulatory Communications: Lead on communications with regulatory bodies, ensuring effective collaboration and resolution of any issues.
  • Post-Market Surveillance: Conduct post-market surveillance activities in accordance with regulatory requirements.
  • Regulatory Partnerships: Work with regulators, reimbursement bodies, and Notified Bodies to obtain full benefits from the IDAP pilot programme.

Quality Management Responsibilities

In time, you will take on quality management responsibilities as the Management Quality Representative, overseeing all aspects of the QMS, including:

  • ISO13485 Certification: Achieve and maintain full-scope ISO13485 certification.
  • QMS Records: Approve QMS records, ensuring accuracy and compliance.
  • Quality Objectives: Deliver on quality objectives, driving continuous improvement.
  • Quality Training: Ensure quality training is up-to-date for all staff, ensuring they understand and follow QMS procedures.
  • Supplier Management: Ensure suppliers are approved and managed according to our QMS.
  • Internal and External Audits: Lead on internal and external audits, ensuring compliance and identifying areas for improvement.
  • eQMS Solution: Transfer from a Sharepoint-based QMS to a full eQMS solution, improving efficiency.
  • MDSAP Certification: Achieve MDSAP certification to enable access to markets requiring it.
  • Quality Team Management: Manage quality personnel as the team grows.

Qualifications and Experience

We are looking for a candidate with:

  • Relevant Degree: A degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
  • Regulatory Experience: 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).
  • Regulatory Expertise: '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.
  • Quality Management: Experience managing a quality system, ISO compliance, and internal and external audits.
  • Excellent Skills: Excellent organisational, 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 Qualifications

We also welcome candidates with experience in:

  • Software as a Medical Device: Experience gaining approval for new Software as a Medical Device products and/or connected devices.
  • Regulatory Approval: Experience gaining regulatory approval for a self-test.
  • Quality Management Rep: Experience as a Quality Management Rep or PRRC.
  • ISO13485 Certification: Experience gaining ISO13485 certification from scratch.
  • Notified Body: Experience working in a Notified Body or equivalent.

Benefits

At 52North, we believe in taking care of our team members both in and outside of the office. We offer a comprehensive benefits package, including:

  • 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, so we offer a flexible work schedule.
  • Generous Holiday Allowance: 28 days of paid holiday plus bank holidays every year, plus an extra day off for every two years of service with us.
  • Maternity, Paternity, and Adoption Policies: Comprehensive policies for maternity, paternity, shared parental leave, and adoption to support our team members in these life-changing moments.
  • EMI Share Option Scheme: Participation in an EMI share option scheme to share in our long-term success.
  • Pension Scheme: A NEST pension scheme with generous employer contributions.
  • Health Insurance: Generous health insurance coverage, including physiotherapy, mental health services, and unlimited virtual GP consultations.
  • Dental and Optical Coverage: Coverage for dental and optical expenses, because we know how important complete healthcare is.
  • Wellbeing Engagement Programme: A 50% discount on certain gym memberships and other wellness resources to promote a healthy lifestyle.
  • Social Activities: Social activities throughout the year and multi-day group retreats to foster a close-knit community.
  • Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge, well connected with public transport and Park & Ride, with free biscuits, cake, tea, and coffee, and beautiful countryside views.

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