Biotech Regulatory Lead
3 weeks ago
Singular is seeking a seasoned Biotech Regulatory Lead to drive regulatory affairs strategy and ensure compliance with global medical device directives.
Estimated Salary: £90,000 - £125,000 per annum
About the CompanyOur client, a world-leading biotech company, operates a UK-based Clinical Laboratory in Guildford and is expanding its services globally.
- The company has developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner.
- They are pushing the boundaries of cancer diagnostics and personalised medicine with their groundbreaking system, the first FDA-cleared device of its kind.
The successful applicant will:
- Define regulatory strategies for new product development.
- Guide clinical and analytical validation studies.
- Liaise with regulatory authorities to ensure compliance.
-
Biotech Regulatory Affairs Leader
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAs a Biotech Regulatory Affairs Leader at Singular: Building Brilliant Biotechs, you will play a pivotal role in shaping the regulatory strategy for our cutting-edge cancer diagnostic technology. Your expertise in IVD medical device product development, adhering to standards such as ISO14971, will be instrumental in ensuring compliance with international...
-
Biotech Regulatory Compliance Lead
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeKey ResponsibilitiesThe successful Head of Regulatory Affairs will be responsible for 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. You will play an...
-
Biotech Regulatory Head
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout the Job:We are seeking an experienced Regulatory Affairs Director to join our team in Guildford.This key leadership role will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets.The successful candidate will provide strategic direction and...
-
Scientific Biotech Specialist
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeBiotech Pioneer WantedA forward-thinking biotech company is seeking a skilled Scientific Biotech Specialist to spearhead the development of its liquid biopsy technology. This cutting-edge platform captures rare circulating tumour cells from blood for downstream analysis, paving the way for advancements in cancer diagnostics and personalised medicine.The...
-
Regulatory Affairs Director
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeJob OverviewSingular: Building Brilliant Biotechs is a world-leading biotech company at the forefront of liquid biopsy technology. Our patented platform captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine.We are seeking an experienced Regulatory...
-
Regulatory Affairs Expert
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeJob OverviewSingular: Building Brilliant Biotechs seeks an experienced Head of Regulatory Affairs to lead our team in Guildford.This key leadership role involves acting as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring compliance with international medical device directives and regulations worldwide.The ideal candidate will...
-
Regulatory Affairs Director
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout the Role:We are seeking an experienced Compliance Expert to lead our regulatory and quality teams in Guildford.This key leadership role will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets.The successful candidate will provide strategic...
-
Biotech Regulatory Leader
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeRole SummaryWe are looking for a seasoned regulatory professional to join our team in Guildford.As the Head of Regulatory Affairs, you will provide strategic direction and operational oversight to the regulatory and quality teams.Your expertise in global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards, is essential...
-
Biotech Diagnostic Specialist
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout Singular: Building Brilliant BiotechsWe are a pioneering biotech company at the forefront of liquid biopsy technology. Our patent-protected platform captures rare circulating tumour cells (CTCs) from blood in a minimally invasive way for downstream analysis.Our innovative system offers significant advancements in cancer diagnostics and personalised...
-
Oncology Diagnostic Project Manager
5 days ago
Guildford, Surrey, United Kingdom Singular Biotech Full timeWe are working on a revolutionary medical device for the collection of circulating tumour cells at Singular Biotech. This innovation has the potential to change the way we diagnose and treat cancer.The role of Clinical Study Manager is crucial in taking our technology to the next level. We are looking for someone with extensive experience in leading clinical...
-
Regulatory Compliance Specialist
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeOur client, a world-leading biotech company, is seeking an experienced Regulatory Compliance Specialist to join their team in Guildford. As a 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...
-
Biotech Diagnostic Specialist
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout the RoleThis is a challenging opportunity to join Singular: Building Brilliant Biotechs as a Clinical Scientist, Technology Transfer. You will be responsible for transferring validated assays from R&D into clinical use.Your Key ResponsibilitiesEnsure smooth and seamless assay validation, verification, and implementation within the clinical...
-
Biotech Clinical Research Specialist
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAs a Clinical Scientist at Singular: Building Brilliant Biotechs, you will play a pivotal role in transferring validated assays from R&D into clinical use.In this exciting position, you will be part of a newly established team of experts focused on ensuring smooth and seamless assay validation, verification, and implementation within the clinical...
-
Regulatory Affairs Leader
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeSingular: Building Brilliant Biotechs is seeking a Regulatory Affairs Leader to drive compliance and ensure the success of their innovative cancer diagnostic technology.This role involves providing expert guidance on regulatory requirements and ensuring the organisation meets all relevant standards.The ideal candidate will have a strong background in IVD...
-
Regulatory Affairs Director
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout the RoleWe are seeking an experienced Head of Regulatory Affairs to join Singular: Building Brilliant Biotechs' team in Guildford. As a key leadership figure, you will oversee regulatory compliance for MDR/IVDR, ensuring the organisation meets all relevant standards across global markets. You will provide strategic direction and operational oversight...
-
Biotech Diagnostic Expert
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeSingular, a pioneering biotech entity, is seeking a talented Clinical Scientist to join its team. This individual will play a crucial role in transferring validated assays from R&D into clinical use, ensuring seamless validation, verification, and implementation within the clinical laboratory.About the Role:Transfer assays for clinical use while maintaining...
-
Biotech Research Scientist
4 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeSingular: Building Brilliant BiotechsSalary: $120,000 - $150,000 per annumAbout the RoleThis is an exciting opportunity to join our team as a Clinical Scientist, Technology Transfer. As a key member of our newly established team, you will play a crucial role in transferring validated assays from R&D into clinical use.You will be responsible for ensuring...
-
Regulatory Affairs Expert
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeJob OverviewSingular, a pioneer in building brilliant biotechs, seeks an experienced Regulatory Affairs Expert to spearhead regulatory compliance across global markets.Estimated Salary: £80,000 - £110,000 per annumAbout the RoleThis key leadership position requires expertise in IVD medical device product development, adhering to standards such as ISO14971....
-
Director of Regulatory Compliance
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeSingular: Building Brilliant Biotechs seeks a Director of Regulatory Compliance to join their team in Guildford. This key leadership role will involve ensuring the organisation meets all relevant regulatory standards across global markets.The ideal candidate will have experience in IVD medical device product development, adhering to standards such as...
-
Medical Device Regulatory Expert
3 weeks ago
Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeAbout the OpportunitySingular: Building Brilliant Biotechs is seeking an experienced Head of Regulatory Affairs to join its team in Guildford. As a key member of the team, you will be responsible for ensuring the organisation meets all relevant regulatory standards across global markets. You will provide strategic direction and operational oversight to the...