Head of Quality and Regulatory Affairs
16 hours ago
52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives by innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.
Job OverviewWe are looking for a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team. 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.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with UK, EU, and FDA regulations.
- Inform and train 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 relevant international standards and guidelines.
- Lead preparation of regulatory submissions, including for FDA approval, UKCA, and CE marking.
- Communicate with regulatory bodies and ensure post-market surveillance activities are conducted in accordance with regulatory requirements.
We are looking for a candidate with a 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 is required, with at least 1 year in IVDs specifically. Experience managing a quality system, ISO compliance, and internal and external audits is also necessary.
BenefitsAt 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, flexible schedules, generous holiday allowances, maternity, paternity, and adoption policies, EMI share option schemes, pension schemes, health insurance, dental and optical coverage, wellbeing engagement programmes, and social activities.
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