Head of Quality and Regulatory Affairs
1 week ago
Crowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives by harnessing cutting-edge technology and a human-centered approach.
Job SummaryWe are seeking 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 and de-risking 52North's regulatory strategy for key markets, ensuring device development and validation meets regulatory requirements, and leading preparation of regulatory submissions.
Key Responsibilities- Develop and implement a robust regulatory strategy for 52North's products, ensuring compliance with UK, EU, and FDA regulations.
- Provide training and guidance to team members on regulatory requirements and changes.
- Lead the preparation of regulatory submissions, including FDA approval, UKCA, and CE marking.
- Communicate effectively with regulatory bodies and ensure post-market surveillance activities are conducted in accordance with regulations.
- Assume quality management responsibilities as Management Quality Representative, overseeing all aspects of the QMS, including quality objectives, training, and process improvements.
- 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 and external audits.
52North is an equal opportunity employer committed to providing a comprehensive benefits package, including a robust pension scheme, health insurance, and a generous holiday allowance. We foster a close-knit community with social activities and a beautiful office space in the heart of Cambridge.
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Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives by harnessing cutting-edge technology and a human-centered approach.Job SummaryWe are...
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Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives by harnessing cutting-edge technology and a human-centered approach.Job SummaryWe are...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and technology-driven approaches that prioritize...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and technology-driven approaches that prioritize...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and cutting-edge technology that prioritizes...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and cutting-edge technology that prioritizes...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and cutting-edge technology that prioritizes...
-
Head of Quality and Regulatory Affairs
1 week ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthCrowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a pioneering med-tech company dedicated to revolutionizing healthcare journeys worldwide. Our mission is to empower people to live better lives through innovative, collaborative, and cutting-edge technology that prioritizes...
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Head of Quality and Regulatory Affairs
7 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a pioneering med-tech company that's revolutionizing healthcare journeys worldwide. As the creators of Neutrocheck, we're committed to innovating, collaborating, and harnessing cutting-edge technology to improve patient experiences and set new industry standards.Job DescriptionWe're seeking a proactive and dedicated Head of Quality...
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Head of Quality and Regulatory Affairs
7 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a pioneering med-tech company that's revolutionizing healthcare journeys worldwide. As the creators of Neutrocheck, we're committed to innovating, collaborating, and harnessing cutting-edge technology to improve patient experiences and set new industry standards.Job DescriptionWe're seeking a proactive and dedicated Head of Quality...
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Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a pioneering med-tech company that is revolutionizing healthcare journeys for people worldwide. As a company, we aim to reinvent healthcare by innovating, collaborating, and leveraging cutting-edge technology that puts people at its core.Key ResponsibilitiesAs the Head of Quality and Regulatory Affairs, you will be responsible...
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Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a pioneering med-tech company that is revolutionizing healthcare journeys for people worldwide. As a company, we aim to reinvent healthcare by innovating, collaborating, and leveraging cutting-edge technology that puts people at its core.Key ResponsibilitiesAs the Head of Quality and Regulatory Affairs, you will be responsible...
-
Head of Quality and Regulatory Affairs
2 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to revolutionise healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as...
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Head of Quality and Regulatory Affairs
2 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to revolutionise healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North 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 MissionWe strive to help people live better lives by...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North 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 MissionWe strive to help people live better lives by...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North 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....
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Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North 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....
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Head of Regulatory Affairs
5 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives through 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...
-
Head of Regulatory Affairs
5 days ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives through 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...
