Head of Regulatory Affairs
5 days ago
Head of Quality and Regulatory Affairs
A fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards. This is an exciting opportunity for someone who is passionate about navigating complex regulatory landscapes to bring cutting-edge technologies to market.
You must have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.
Lead Regulatory Strategy: Develop and execute the regulatory strategy for all products across key international markets.
Provide Regulatory Guidance: Ensure the team is up-to-date on global regulatory changes and train team members on regulatory requirements.
Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.Additionally, the Head of Quality will manage the company's quality systems, including:
Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation. Ideal candidates will be passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards.
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Head of Regulatory Affairs
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Cambridge, United Kingdom BioTalent Full timeJob Title: Head of Quality Assurance and Regulatory AffairsLocation: Hybrid About Us:This company is at the forefront of the personalized medicine revolution. They are a dynamic and innovative company dedicated to optimizing the treatment of chronic diseases through a unique approach that combines precision medicine, digital health, and data...
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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...
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Head of Quality and Regulatory Affairs
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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...
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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...
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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...
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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...
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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
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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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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...