Medical Device Compliance Manager

7 days ago


Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time
Regulatory Compliance Specialist

Singular is looking for a highly skilled Medical Device Compliance Manager to oversee regulatory compliance across the organisation.

Estimated Salary: £95,000 - £130,000 per annum

About the Team

The regulatory and quality teams work closely together to ensure the organisation meets all relevant regulatory standards.

  • The team provides strategic direction and operational oversight to ensure compliance with international medical device directives.
  • They manage compliance with ISO13485 and ISO15189 standards.
Key Responsibilities

The successful applicant will:

  • Manage compliance with international regulatory frameworks.
  • Provide strategic direction to the regulatory and quality teams.
  • Oversight operational activities to ensure compliance.


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Job SummaryWe are seeking a highly experienced Medical Device Compliance Manager to join our team in Guildford. This is an exciting opportunity to lead our regulatory efforts and ensure compliance with global medical device regulations.In this role, you will be responsible for developing and implementing regulatory strategies to support new product...

  • Compliance Leader

    7 days ago


    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant BiotechsJob DescriptionWe are looking for a skilled Medical Device Compliance Specialist to lead our regulatory affairs team. As the Head of Regulatory Affairs, you will be responsible for ensuring our organisation's products meet the required regulatory standards worldwide.Key responsibilities include providing strategic...


  • Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    Senior Quality Assurance Specialist for Medical DevicesMV | MysteryVibe is seeking an experienced Senior Quality Assurance Specialist to lead the development and implementation of Quality Management Systems (QMS) for ISO 13485 certification. This role requires close collaboration with product development and manufacturing teams to ensure alignment with...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant BiotechsOpportunity OverviewWe are seeking a highly experienced Regulatory Affairs Director to join our team in Guildford. This senior leadership role involves overseeing our regulatory affairs strategy, ensuring our organisation meets all relevant regulatory standards across global markets.You will lead the regulatory and...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant Biotechs is looking for a Medical Device Director to lead our regulatory affairs function. As a senior leader, you will define regulatory strategies, guide clinical and analytical validation studies, and liaise with regulatory authorities to ensure compliance with international medical device directives and regulations.The ideal...


  • Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    MV | MysteryVibe is an award-winning leader in women's & men's health devices, creating clinically proven medical devices that adapt to the user's body & deliver targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder & erectile dysfunction.We are embarking on getting ISO 13485 certification, and we need a talented Regulatory...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    About 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...

  • Compliance Manager

    7 days ago


    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant Biotechs requires a Compliance Manager to oversee the implementation of regulatory standards and ensure the organisation remains compliant with international medical device directives.This role involves managing a team of regulatory professionals and providing guidance on regulatory requirements.The ideal candidate will have...

  • Biostatistics Lead

    1 month ago


    Guildford, Surrey, United Kingdom Gb Tech Full time

    Job SummaryWe are seeking an experienced Biostatistics Lead - Medical Devices to join our team at Gb Tech. As a key member of our data analytics department, you will be responsible for leading the statistical analysis of clinical studies and ensuring high-quality data models.Key Responsibilities:Lead or contribute to the statistical analysis of clinical...

  • Compliance Manager

    7 days ago


    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Key ResponsibilitiesIn this exciting opportunity, you will play a crucial role in new product development (NPD) by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities.You will also manage compliance with international medical device directives and regulations, including ISO13485 and...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: 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...


  • Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    We are looking for a Regulatory Compliance Specialist to join our team at MV | MysteryVibe, a company dedicated to improving women's and men's healthcare through clinically proven medical devices. The successful candidate will be responsible for creating and managing the necessary documentation and processes for ISO 13485 certification.About the RoleThis...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Key ResponsibilitiesAs our ideal candidate, you will have a strong background in IVD medical device product development and a deep understanding of global medical device directives.You will be responsible for leading our regulatory efforts, developing and implementing regulatory strategies to support new product development and commercialisation.You will...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Key ResponsibilitiesAs our new Head of Regulatory Affairs, you will define regulatory strategies, guide clinical and analytical validation studies, and liaise with regulatory authorities to ensure global commercial rollout of our revolutionary cancer diagnostic technology.You will provide strategic direction and operational oversight to the regulatory and...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Our 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...


  • Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    We are looking for a Quality Assurance Manager for Medical Devices to join our team at MV | MysteryVibe. As a Quality Assurance Manager, you will oversee the development and implementation of our Quality Management System (QMS) for ISO 13485 certification.You will be responsible for creating and managing technical files, SOPs, risk management reports, and...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    About the Opportunity:This exciting opportunity allows you to influence the global commercial rollout of a revolutionary cancer diagnostic technology.You will be part of a dynamic and innovative biotech company dedicated to advancing cancer diagnostics and personalised medicine.The company values innovation, collaboration, and excellence, and is committed to...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    About 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...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant BiotechsJob Title:Head of Regulatory AffairsAbout the RoleWe are seeking an experienced Compliance Leader - Medical Devices to join our team in Guildford. This key leadership role involves acting as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory...


  • Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    About 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...