Head of Quality and Regulatory Affairs
5 days ago
About 52North
52North is a leading med-tech company that aims to revolutionize healthcare journeys for people worldwide. As a pioneer in the industry, we are committed to innovating, collaborating, and leveraging cutting-edge technology to improve patient experiences and set new industry standards.
Our Mission
We strive to help people live better lives by integrating technology with a human-centered approach. Our flagship product, Neutrocheck, has been recognized as one of the top technologies globally for the UK government's Innovative Devices Access Pathway (IDAP) pilot programme.
Job Overview
We are seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team. As a key member of our organization, you will be responsible for ensuring seamless regulatory approval processes and navigating the complexities of the regulatory landscape.
Key Responsibilities:
- Develop and implement a comprehensive regulatory strategy for key markets and all potential 52North products.
- Provide training and guidance to team members on regulatory requirements and stay up-to-date with regulatory changes globally.
- Ensure device development and validation is conducted and documented in accordance with UK, EU, and FDA regulatory requirements, relevant international standards, and guidelines.
- Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking, and ensure conformance with regulatory requirements.
- Communicate effectively with regulatory bodies and ensure post-market surveillance activities are conducted in accordance with regulatory requirements.
- Work with regulators, reimbursement bodies, and Notified Bodies to obtain full benefit of the IDAP pilot programme.
Additional Responsibilities:
- Manage quality personnel as the team grows.
- Achieve and maintain full-scope ISO13485 certification.
- Approve QMS records and ensure quality training is up-to-date for all staff.
- Ensure suppliers are approved and managed according to our QMS.
- Lead on internal and external audits and transfer from a Sharepoint-based QMS to a full eQMS solution.
- Achieve MDSAP certification to enable access to markets that require it.
Requirements:
- 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 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:
- 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:
- 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.
- Generous Holiday Allowance: We offer 28 days of paid holiday plus bank holidays every year.
- Maternity, Paternity, and Adoption Policies: We have comprehensive policies for maternity, paternity, shared parental leave, and adoption.
- EMI Share Option Scheme: We want our team to be part of our long-term success.
- Pension Scheme: We offer a NEST pension scheme with generous employer contributions.
- Health Insurance: Our Vitality health insurance provides generous coverage.
- Dental and Optical Coverage: We cover dental and optical expenses.
- Wellbeing Engagement Programme: We promote a healthy lifestyle.
- Social Activities: We foster a close-knit community.
- Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge.
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