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Head of Quality and Regulatory Affairs
2 months ago
52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. As a leader in medical technology, we strive to make a meaningful impact on people's lives through innovative solutions.
Job SummaryWe are seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to join our dynamic team. This key role will be responsible for ensuring seamless regulatory approval processes for our cutting-edge medical devices, while also driving quality management initiatives across the organization.
Key Responsibilities- Develop and implement a robust regulatory strategy for key markets, ensuring compliance with UK, EU, and FDA regulations.
- Provide expert guidance and training to team members on regulatory requirements, staying up-to-date with global regulatory changes.
- Oversee device development and validation, ensuring adherence to regulatory standards and guidelines.
- Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking.
- Communicate effectively with regulatory bodies, ensuring timely and accurate responses.
- Conduct post-market surveillance activities in accordance with regulatory requirements.
- Assume quality management responsibilities as Management Quality Representative, overseeing all aspects of the QMS.
- Degree in law, medicine, pharmacy, engineering, or a relevant scientific discipline.
- At least 5 years' experience in regulatory affairs and quality management in medical devices, with a minimum of 1 year in IVDs (EU MDD/MDR, EU IVDD/IVDR, US FDA Class II/III).
- Proven track record of delivering projects, designing and implementing processes, and working collaboratively in a fast-paced team.
- Experience managing a quality system, ISO compliance, and internal/external audits.
- Knowledge of regulatory approval processes for Software as a Medical Device products and connected devices.
- Experience as a Quality Management Representative or Person Responsible for Regulatory Compliance.
At 52North, we prioritize our team's well-being and growth. Our comprehensive benefits package includes:
- Hybrid working arrangement, allowing flexibility between home and office.
- Flexible schedule to accommodate individual needs and rhythms.
- Generous holiday allowance, including additional days off for every two years of service.
- Comprehensive maternity, paternity, and adoption policies.
- EMI share option scheme, enabling team members to participate in our long-term success.
- Pension scheme with generous employer contributions.
- Health insurance, including physiotherapy, mental health services, and virtual GP consultations.
- Dental and optical coverage.
- Wellbeing engagement program, promoting a healthy lifestyle.
- Social activities and multi-day group retreats.
- Office perks, including free snacks, tea, and coffee, and beautiful countryside views.
