Regulatory Affairs
2 weeks ago
Head of Regulatory Affairs
Our client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their groundbreaking system, the first FDA-cleared device of its kind, enables the collection and analysis of intact circulating cancer cells, offering new insights into metastatic disease. The company operates a UK-based Clinical Laboratory in Guildford and is expanding its services globally, integrating advanced molecular profiling techniques such as digital PCR and NGS.
We are seeking an experienced Head of Regulatory Affairs to join our client’s team in Guildford. In this key leadership role, you will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets. You will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO13485 and ISO15189.
You will play an essential role in new product development (NPD) by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities. This position offers the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology.
Experience in IVD medical device product development, adhering to standards such as ISO14971.
In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.
If you are an experienced regulatory professional with a passion for innovation in cancer diagnostics, this is an exciting opportunity to make a significant impact.
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Head of Regulatory Affairs
2 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeHead of Regulatory Affairs THE COMPANY Our client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their...
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Regulatory Affairs Director
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Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeJob DescriptionHead of Regulatory AffairsSingular: Building Brilliant Biotechs is seeking a seasoned Regulatory Affairs Director to spearhead regulatory compliance across global markets. As the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, you will ensure the organisation meets all relevant regulatory standards.Key...
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Regulatory Affairs Director
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeHead of Regulatory AffairsSingular: Building Brilliant Biotechs is seeking a seasoned Head of Regulatory Affairs to lead our regulatory and quality teams in Guildford. As the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, you will ensure our organisation meets all relevant regulatory standards across global markets.Key...
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Regulatory Affairs Director
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeLead Regulatory Affairs for a Groundbreaking Biotech CompanySingular is seeking an experienced Head of Regulatory Affairs to join our team in Guildford. As a key member of our organization, you will be responsible for ensuring compliance with international medical device directives and regulations, including ISO13485 and ISO15189.Key Responsibilities:Act as...
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Regulatory Affairs Director
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeRevolutionize Cancer Diagnostics as Head of Regulatory AffairsSingular: Building Brilliant Biotechs is at the forefront of liquid biopsy technology, and we're seeking an experienced Head of Regulatory Affairs to join our team in Guildford.About the RoleAs the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, you will ensure our organisation...
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Regulatory Affairs Director
2 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeRole OverviewSingular: Building Brilliant Biotechs is at the forefront of liquid biopsy technology, developing a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner.The CompanyOur client operates a UK-based Clinical Laboratory in Guildford and is expanding its services globally, integrating...
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Head of Regulatory Affairs
3 weeks ago
Guildford, United Kingdom Singular: Building Brilliant Biotechs Full timeHead of Regulatory AffairsTHE COMPANYOur client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their...
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Head of Regulatory Affairs
1 month ago
Guildford, United Kingdom Singular: Building Brilliant Biotechs Full timeHead of Regulatory AffairsTHE COMPANYOur client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their...
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Head of Regulatory Affairs
4 weeks ago
Guildford, United Kingdom Singular: Building Brilliant Biotechs Full timeHead of Regulatory AffairsTHE COMPANYOur client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine. Their...
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Head of Regulatory Affairs
2 weeks ago
Guildford, United Kingdom Singular: Building Brilliant Biotechs Full timeJob Description Head of Regulatory Affairs THE COMPANY Our client, a world-leading biotech company, is at the forefront of liquid biopsy technology. They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised...
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Regulatory Affairs
2 weeks ago
Egham, Surrey, United Kingdom Northreach Full timeNorthreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth. We have partnered...
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Regulatory Affairs Specialist
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2 weeks ago
Surrey Heath, United Kingdom CY Partners Full timeBrilliant entry level opportunty for graduates with a scientific background. You will join the team as Raw Material Specialist working with both the R&D team and Suppliers. The function of the role is to support the technical aspects of managing raw material data, building awareness of key chemical legislations (REACH, CLP, GPSR, CSR). You will recieve...
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Regulatory Affairs Specialist
1 week ago
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Regulatory Affairs Specialist
6 days ago
Surrey, United Kingdom CY Partners Full timeJob Description Brilliant entry level opportunty for graduates with a scientific background. You will join the team as Raw Material Specialist working with both the R&D team and Suppliers. The function of the role is to support the technical aspects of managing raw material data, building awareness of key chemical legislations (REACH, CLP, GPSR, CSR). You...
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Regulatory Affairs Specialist
1 week ago
Surrey, United Kingdom CY Partners Full timeBrilliant entry level opportunty for graduates with a scientific background. You will join the team as Raw Material Specialist working with both the R&D team and Suppliers. The function of the role is to support the technical aspects of managing raw material data, building awareness of key chemical legislations (REACH, CLP, GPSR, CSR). You will recieve...
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Graduate Regulatory Affairs
2 weeks ago
Surrey Heath, United Kingdom CY Partners Full timeBrilliant entry level opportunty for graduates with a scientific background. You will join the team as Raw Material Specialist working with both the R&D team and Suppliers. The function of the role is to support the technical aspects of managing raw material data, building awareness of key chemical legislations (REACH, CLP, GPSR, CSR). You will recieve...
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Regulatory Affairs Specialist
3 weeks ago
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